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1.  Utilization of DXA Bone Mineral Densitometry in Ontario 
Executive Summary
Issue
Systematic reviews and analyses of administrative data were performed to determine the appropriate use of bone mineral density (BMD) assessments using dual energy x-ray absorptiometry (DXA), and the associated trends in wrist and hip fractures in Ontario.
Background
Dual Energy X-ray Absorptiometry Bone Mineral Density Assessment
Dual energy x-ray absorptiometry bone densitometers measure bone density based on differential absorption of 2 x-ray beams by bone and soft tissues. It is the gold standard for detecting and diagnosing osteoporosis, a systemic disease characterized by low bone density and altered bone structure, resulting in low bone strength and increased risk of fractures. The test is fast (approximately 10 minutes) and accurate (exceeds 90% at the hip), with low radiation (1/3 to 1/5 of that from a chest x-ray). DXA densitometers are licensed as Class 3 medical devices in Canada. The World Health Organization has established criteria for osteoporosis and osteopenia based on DXA BMD measurements: osteoporosis is defined as a BMD that is >2.5 standard deviations below the mean BMD for normal young adults (i.e. T-score <–2.5), while osteopenia is defined as BMD that is more than 1 standard deviation but less than 2.5 standard deviation below the mean for normal young adults (i.e. T-score< –1 & ≥–2.5). DXA densitometry is presently an insured health service in Ontario.
Clinical Need
 
Burden of Disease
The Canadian Multicenter Osteoporosis Study (CaMos) found that 16% of Canadian women and 6.6% of Canadian men have osteoporosis based on the WHO criteria, with prevalence increasing with age. Osteopenia was found in 49.6% of Canadian women and 39% of Canadian men. In Ontario, it is estimated that nearly 530,000 Ontarians have some degrees of osteoporosis. Osteoporosis-related fragility fractures occur most often in the wrist, femur and pelvis. These fractures, particularly those in the hip, are associated with increased mortality, and decreased functional capacity and quality of life. A Canadian study showed that at 1 year after a hip fracture, the mortality rate was 20%. Another 20% required institutional care, 40% were unable to walk independently, and there was lower health-related quality of life due to attributes such as pain, decreased mobility and decreased ability to self-care. The cost of osteoporosis and osteoporotic fractures in Canada was estimated to be $1.3 billion in 1993.
Guidelines for Bone Mineral Density Testing
With 2 exceptions, almost all guidelines address only women. None of the guidelines recommend blanket population-based BMD testing. Instead, all guidelines recommend BMD testing in people at risk of osteoporosis, predominantly women aged 65 years or older. For women under 65 years of age, BMD testing is recommended only if one major or two minor risk factors for osteoporosis exist. Osteoporosis Canada did not restrict its recommendations to women, and thus their guidelines apply to both sexes. Major risk factors are age greater than or equal to 65 years, a history of previous fractures, family history (especially parental history) of fracture, and medication or disease conditions that affect bone metabolism (such as long-term glucocorticoid therapy). Minor risk factors include low body mass index, low calcium intake, alcohol consumption, and smoking.
Current Funding for Bone Mineral Density Testing
The Ontario Health Insurance Program (OHIP) Schedule presently reimburses DXA BMD at the hip and spine. Measurements at both sites are required if feasible. Patients at low risk of accelerated bone loss are limited to one BMD test within any 24-month period, but there are no restrictions on people at high risk. The total fee including the professional and technical components for a test involving 2 or more sites is $106.00 (Cdn).
Method of Review
This review consisted of 2 parts. The first part was an analysis of Ontario administrative data relating to DXA BMD, wrist and hip fractures, and use of antiresorptive drugs in people aged 65 years and older. The Institute for Clinical Evaluative Sciences extracted data from the OHIP claims database, the Canadian Institute for Health Information hospital discharge abstract database, the National Ambulatory Care Reporting System, and the Ontario Drug Benefit database using OHIP and ICD-10 codes. The data was analyzed to examine the trends in DXA BMD use from 1992 to 2005, and to identify areas requiring improvement.
The second part included systematic reviews and analyses of evidence relating to issues identified in the analyses of utilization data. Altogether, 8 reviews and qualitative syntheses were performed, consisting of 28 published systematic reviews and/or meta-analyses, 34 randomized controlled trials, and 63 observational studies.
Findings of Utilization Analysis
Analysis of administrative data showed a 10-fold increase in the number of BMD tests in Ontario between 1993 and 2005.
OHIP claims for BMD tests are presently increasing at a rate of 6 to 7% per year. Approximately 500,000 tests were performed in 2005/06 with an age-adjusted rate of 8,600 tests per 100,000 population.
Women accounted for 90 % of all BMD tests performed in the province.
In 2005/06, there was a 2-fold variation in the rate of DXA BMD tests across local integrated health networks, but a 10-fold variation between the county with the highest rate (Toronto) and that with the lowest rate (Kenora). The analysis also showed that:
With the increased use of BMD, there was a concomitant increase in the use of antiresorptive drugs (as shown in people 65 years and older) and a decrease in the rate of hip fractures in people age 50 years and older.
Repeat BMD made up approximately 41% of all tests. Most of the people (>90%) who had annual BMD tests in a 2-year or 3-year period were coded as being at high risk for osteoporosis.
18% (20,865) of the people who had a repeat BMD within a 24-month period and 34% (98,058) of the people who had one BMD test in a 3-year period were under 65 years, had no fracture in the year, and coded as low-risk.
Only 19% of people age greater than 65 years underwent BMD testing and 41% received osteoporosis treatment during the year following a fracture.
Men accounted for 24% of all hip fractures and 21 % of all wrist fractures, but only 10% of BMD tests. The rates of BMD tests and treatment in men after a fracture were only half of those in women.
In both men and women, the rate of hip and wrist fractures mainly increased after age 65 with the sharpest increase occurring after age 80 years.
Findings of Systematic Review and Analysis
Serial Bone Mineral Density Testing for People Not Receiving Osteoporosis Treatment
A systematic review showed that the mean rate of bone loss in people not receiving osteoporosis treatment (including postmenopausal women) is generally less than 1% per year. Higher rates of bone loss were reported for people with disease conditions or on medications that affect bone metabolism. In order to be considered a genuine biological change, the change in BMD between serial measurements must exceed the least significant change (variability) of the testing, ranging from 2.77% to 8% for precisions ranging from 1% to 3% respectively. Progression in BMD was analyzed, using different rates of baseline BMD values, rates of bone loss, precision, and BMD value for initiating treatment. The analyses showed that serial BMD measurements every 24 months (as per OHIP policy for low-risk individuals) is not necessary for people with no major risk factors for osteoporosis, provided that the baseline BMD is normal (T-score ≥ –1), and the rate of bone loss is less than or equal to 1% per year. The analyses showed that for someone with a normal baseline BMD and a rate of bone loss of less than 1% per year, the change in BMD is not likely to exceed least significant change (even for a 1% precision) in less than 3 years after the baseline test, and is not likely to drop to a BMD level that requires initiation of treatment in less than 16 years after the baseline test.
Serial Bone Mineral Density Testing in People Receiving Osteoporosis Therapy
Seven published meta-analysis of randomized controlled trials (RCTs) and 2 recent RCTs on BMD monitoring during osteoporosis therapy showed that although higher increases in BMD were generally associated with reduced risk of fracture, the change in BMD only explained a small percentage of the fracture risk reduction.
Studies showed that some people with small or no increase in BMD during treatment experienced significant fracture risk reduction, indicating that other factors such as improved bone microarchitecture might have contributed to fracture risk reduction.
There is conflicting evidence relating to the role of BMD testing in improving patient compliance with osteoporosis therapy.
Even though BMD may not be a perfect surrogate for reduction in fracture risk when monitoring responses to osteoporosis therapy, experts advised that it is still the only reliable test available for this purpose.
A systematic review conducted by the Medical Advisory Secretariat showed that the magnitude of increases in BMD during osteoporosis drug therapy varied among medications. Although most of the studies yielded mean percentage increases in BMD from baseline that did not exceed the least significant change for a 2% precision after 1 year of treatment, there were some exceptions.
Bone Mineral Density Testing and Treatment After a Fragility Fracture
A review of 3 published pooled analyses of observational studies and 12 prospective population-based observational studies showed that the presence of any prevalent fracture increases the relative risk for future fractures by approximately 2-fold or more. A review of 10 systematic reviews of RCTs and 3 additional RCTs showed that therapy with antiresorptive drugs significantly reduced the risk of vertebral fractures by 40 to 50% in postmenopausal osteoporotic women and osteoporotic men, and 2 antiresorptive drugs also reduced the risk of nonvertebral fractures by 30 to 50%. Evidence from observational studies in Canada and other jurisdictions suggests that patients who had undergone BMD measurements, particularly if a diagnosis of osteoporosis is made, were more likely to be given pharmacologic bone-sparing therapy. Despite these findings, the rate of BMD investigation and osteoporosis treatment after a fracture remained low (<20%) in Ontario as well as in other jurisdictions.
Bone Mineral Density Testing in Men
There are presently no specific Canadian guidelines for BMD screening in men. A review of the literature suggests that risk factors for fracture and the rate of vertebral deformity are similar for men and women, but the mortality rate after a hip fracture is higher in men compared with women. Two bisphosphonates had been shown to reduce the risk of vertebral and hip fractures in men. However, BMD testing and osteoporosis treatment were proportionately low in Ontario men in general, and particularly after a fracture, even though men accounted for 25% of the hip and wrist fractures. The Ontario data also showed that the rates of wrist fracture and hip fracture in men rose sharply in the 75- to 80-year age group.
Ontario-Based Economic Analysis
The economic analysis focused on analyzing the economic impact of decreasing future hip fractures by increasing the rate of BMD testing in men and women age greater than or equal to 65 years following a hip or wrist fracture. A decision analysis showed the above strategy, especially when enhanced by improved reporting of BMD tests, to be cost-effective, resulting in a cost-effectiveness ratio ranging from $2,285 (Cdn) per fracture avoided (worst-case scenario) to $1,981 (Cdn) per fracture avoided (best-case scenario). A budget impact analysis estimated that shifting utilization of BMD testing from the low risk population to high risk populations within Ontario would result in a saving of $0.85 million to $1.5 million (Cdn) to the health system. The potential net saving was estimated at $1.2 million to $5 million (Cdn) when the downstream cost-avoidance due to prevention of future hip fractures was factored into the analysis.
Other Factors for Consideration
There is a lack of standardization for BMD testing in Ontario. Two different standards are presently being used and experts suggest that variability in results from different facilities may lead to unnecessary testing. There is also no requirement for standardized equipment, procedure or reporting format. The current reimbursement policy for BMD testing encourages serial testing in people at low risk of accelerated bone loss. This review showed that biannual testing is not necessary for all cases. The lack of a database to collect clinical data on BMD testing makes it difficult to evaluate the clinical profiles of patients tested and outcomes of the BMD tests. There are ministry initiatives in progress under the Osteoporosis Program to address the development of a mandatory standardized requisition form for BMD tests to facilitate data collection and clinical decision-making. Work is also underway for developing guidelines for BMD testing in men and in perimenopausal women.
Conclusion
Increased use of BMD in Ontario since 1996 appears to be associated with increased use of antiresorptive medication and a decrease in hip and wrist fractures.
Data suggest that as many as 20% (98,000) of the DXA BMD tests in Ontario in 2005/06 were performed in people aged less than 65 years, with no fracture in the current year, and coded as being at low risk for accelerated bone loss; this is not consistent with current guidelines. Even though some of these people might have been incorrectly coded as low-risk, the number of tests in people truly at low risk could still be substantial.
Approximately 4% (21,000) of the DXA BMD tests in 2005/06 were repeat BMDs in low-risk individuals within a 24-month period. Even though this is in compliance with current OHIP reimbursement policies, evidence showed that biannual serial BMD testing is not necessary in individuals without major risk factors for fractures, provided that the baseline BMD is normal (T-score < –1). In this population, BMD measurements may be repeated in 3 to 5 years after the baseline test to establish the rate of bone loss, and further serial BMD tests may not be necessary for another 7 to 10 years if the rate of bone loss is no more than 1% per year. Precision of the test needs to be considered when interpreting serial BMD results.
Although changes in BMD may not be the perfect surrogate for reduction in fracture risk as a measure of response to osteoporosis treatment, experts advised that it is presently the only reliable test for monitoring response to treatment and to help motivate patients to continue treatment. Patients should not discontinue treatment if there is no increase in BMD after the first year of treatment. Lack of response or bone loss during treatment should prompt the physician to examine whether the patient is taking the medication appropriately.
Men and women who have had a fragility fracture at the hip, spine, wrist or shoulder are at increased risk of having a future fracture, but this population is presently under investigated and under treated. Additional efforts have to be made to communicate to physicians (particularly orthopaedic surgeons and family physicians) and the public about the need for a BMD test after fracture, and for initiating treatment if low BMD is found.
Men had a disproportionately low rate of BMD tests and osteoporosis treatment, especially after a fracture. Evidence and fracture data showed that the risk of hip and wrist fractures in men rises sharply at age 70 years.
Some counties had BMD utilization rates that were only 10% of that of the county with the highest utilization. The reasons for low utilization need to be explored and addressed.
Initiatives such as aligning reimbursement policy with current guidelines, developing specific guidelines for BMD testing in men and perimenopausal women, improving BMD reports to assist in clinical decision making, developing a registry to track BMD tests, improving access to BMD tests in remote/rural counties, establishing mechanisms to alert family physicians of fractures, and educating physicians and the public, will improve the appropriate utilization of BMD tests, and further decrease the rate of fractures in Ontario. Some of these initiatives such as developing guidelines for perimenopausal women and men, and developing a standardized requisition form for BMD testing, are currently in progress under the Ontario Osteoporosis Strategy.
PMCID: PMC3379167  PMID: 23074491
2.  Breakout Session: Sex/Gender and Racial/Ethnic Disparities in the Care of Osteoporosis and Fragility Fractures 
Background
Recent epidemiologic and clinical data suggest men and racial and ethnic minorities may receive lower-quality care for osteoporosis and fragility fractures than female and nonminority patients. The causes of such differences and optimal strategies for their reduction are unknown.
Questions/purposes
A panel was convened at the May 2010 American Academy of Orthopaedic Surgeons/Orthopaedic Research Society/Association of Bone and Joint Surgeons Musculoskeletal Healthcare Disparities Research Symposium to (1) assess current understanding of sex/gender and racial/ethnic disparities in the care of osteoporosis and after fragility fractures, (2) define goals for improving the equity and quality of care, and (3) identify strategies for achieving these goals.
Where are we now?
Participants identified shortcomings in the quality of care for osteoporosis and fragility fractures among male and minority populations and affirmed a need for novel strategies to improve the quality and equity of care.
Where do we need to go?
Participants agreed opportunities exist for health professionals to contribute to improved osteoporosis management and secondary fracture prevention. They agreed on a need to define standards of care and management for osteoporosis and fragility fractures and develop strategies to involve physicians and other health professionals in improving care.
How do we get there?
The group proposed strategies to improve the quality and equity of osteoporosis and care after fragility fractures. These included increased patient and physician education, with identification of “champions” for osteoporosis care within and outside of the healthcare workforce; creation of incentives for hospitals and physicians to improve care; and research comparing the effectiveness of approaches to osteoporosis screening and fracture management.
doi:10.1007/s11999-011-1859-1
PMCID: PMC3111803  PMID: 21424834
3.  Investigation and treatment of osteoporosis in patients with fragility fractures 
Background
Many patients who have undiagnosed osteoporosis and a recent fragility fracture present to fracture clinics in Canadian hospitals, where the focus of management is on fracture care. The rate of diagnosis and treatment of osteoporosis in this patient group is unknown.
Methods
Patients who presented with fractures at sites consistent with fragility-type fractures were identified through a retrospective chart review of fracture clinic visits in 3 Ontario community hospitals in selected weeks in February and November 1996 and August and May 1997. These patients were contacted by mail and telephone follow-up to obtain consent to participate in a telephone interview. Patients were excluded if the index fracture had been traumatic, if they were younger than 18 years, or if they had medical conditions known to be associated with secondary bone loss. Eligible patients were questioned about their history of prior fractures, diagnosis of osteoporosis, and investigation and treatment of osteoporosis before or after the index fracture.
Results
Among 2694 fracture clinic visits, we identified 228 patients (8.4%) with fragility-type fractures. Of the 228, 128 (56.1%) were contacted and agreed to participate in an interview about 1 year from the date of the index fracture. Of the 128 patients, 108 (83 postmenopausal and 13 premenopausal women and 12 men) were confirmed as eligible. Of the 108, 43 had experienced 53 fractures in addition to the index fracture in the preceding 10 years, of which 71% were of the fragility type. At interview, only 20 (18.5%) (all postmenopausal women) of the 108 patients reported that they had received a diagnosis of osteoporosis. Of the 20, 90% and 45% respectively had been advised to take calcium and vitamin D supplements; 8 (40%) were receiving hormone replacement therapy (HRT), and 8 (40%) were taking bisphosphonates. Of the 88 patients who had not received a diagnosis of osteoporosis, 4 (4.5%) were receiving HRT, none was taking bisphosphonates, and less than 20% had been advised to take supplemental calcium or vitamin D.
Interpretation
In a representative sample of patients at urban fracture clinics, less than 20% who presented with a fragility-type fracture had undergone investigatation and adequate treatment of osteoporosis at 1-year follow-up. Since previous fracture significantly increases the risk for future fracture, this clearly is a deficiency in management. Through improved identification and treatment of patients with osteoporosis-related fractures who present to fracture clinics, there is a significant opportunity to reduce the rates of illness and death associated with this conditio
PMCID: PMC80503  PMID: 11033708
4.  Balloon Kyphoplasty 
Executive Summary
Objective
To review the evidence on the effectiveness and cost-effectiveness of balloon kyphoplasty for the treatment of vertebral compression fractures (VCFs).
Clinical Need
Vertebral compression fractures are one of the most common types of osteoporotic fractures. They can lead to chronic pain and spinal deformity. They are caused when the vertebral body (the thick block of bone at the front of each vertebra) is too weak to support the loads of activities of daily living. Spinal deformity due to a collapsed vertebral body can substantially affect the quality of life of elderly people, who are especially at risk for osteoporotic fractures due to decreasing bone mass with age. A population-based study across 12 European centres recently found that VCFs have a negative impact on health-related quality of life. Complications associated with VCFs are pulmonary dysfunction, eating disorders, loss of independence, and mental status change due to pain and the use of medications. Osteoporotic VCFs also are associated with a higher rate of death.
VCFs affect an estimated 25% of women over age 50 years and 40% of women over age 80 years. Only about 30% of these fractures are diagnosed in clinical practice. A Canadian multicentre osteoporosis study reported on the prevalence of vertebral deformity in Canada in people over 50 years of age. To define the limit of normality, they plotted a normal distribution, including mean and standard deviations (SDs) derived from a reference population without any deformity. They reported a prevalence rate of 23.5% in women and a rate of 21.5% in men, using 3 SDs from the mean as the limit of normality. When they used 4 SDs, the prevalence was 9.3% and 7.3%, respectively. They also found the prevalence of vertebral deformity increased with age. For people older than 80 years of age, the prevalence for women and men was 45% and 36%, respectively, using 3 SDs as the limit of normality.
About 85% of VCFs are due to primary osteoporosis. Secondary osteoporosis and neoplasms account for the remaining 15%. A VCF is operationally defined as a reduction in vertebral body height of at least 20% from the initial measurement. It is considered mild if the reduction in height is between 20% and 25%; moderate, if it is between 25% and 40%; and severs, if it is more than 40%. The most frequently fractured locations are the third-lower part of the thorax and the superior lumbar levels. The cervical vertebrae and the upper third of the thorax are rarely involved.
Traditionally, bed rest, medication, and bracing are used to treat painful VCFs. However, anti-inflammatory and narcotic medications are often poorly tolerated by the elderly and may harm the gastrointestinal tract. Bed rest and inactivity may accelerate bone loss, and bracing may restrict diaphragmatic movement. Furthermore, medical treatment does not treat the fracture in a way that ameliorates the pain and spinal deformity.
Over the past decade, the injection of bone cement through the skin into a fractured vertebral body has been used to treat VCFs. The goal of cement injection is to reduce pain by stabilizing the fracture. The secondary indication of these procedures is management of painful vertebral fractures caused by benign or malignant neoplasms (e.g., hemangioma, multiple myeloma, and metastatic cancer).
The Technology
Balloon kyphoplasty is a modified vertebroplasty technique. It is a minimally invasive procedure that aims to relieve pain, restore vertebral height, and correct kyphosis. During this procedure, an inflatable bone tamp is inserted into the collapsed vertebral body. Once inflated, the balloon elevates the end plates and thereby restores the height of the vertebral body. The balloon is deflated and removed, and the space is filled with bone cement. Creating a space in the vertebral body enables the application of more viscous cement and at a much lower pressure than is needed for vertebroplasty. This may result in less cement leakage and fewer complications. Balloons typically are inserted bilaterally, into each fractured vertebral body. Kyphoplasty usually is done under general anesthesia in about 1.5 hours. Patients typically are observed for only a few hours after the surgery, but some may require an overnight hospital stay.
Health Canada has licensed KyphX Xpander Inflatable Bone Tamp (Kyphon Inc., Sunnyvale, CA), for kyphoplasty in patients with VCFs. KyphX is the only commercially available device for percutaneous kyphoplasty. The KyphX kit uses a series of bone filler device tubes. Each bone filler device must be loaded manually with cement. The cement is injected into the cavity by pressing an inner stylet.
In the United States, the Food and Drug Administration cleared the KyphX Inflatable Bone Tamp for marketing in July 1998. CE (Conformité European) marketing was obtained in February 2000 for the reduction of fracture and/or creation of a void in cancellous bone.
Review Strategy
The aim of this literature review was to evaluate the safety and effectiveness of balloon kyphoplasty in the treatment of painful VCFs.
INAHTA, Cochrane CCTR (formerly Cochrane Controlled Trials Register), and DSR were searched for health technology assessment reports. In addition, MEDLINE, EMBASE, and MEDLINE In-Process & Other Non-Indexed Citations were searched from January 1, 2000 to September 21, 2004. The search was limited to English-language articles and human studies.
The positive end points selected for this assessment were as follows:
Reduction in pain scores
Reduction in vertebral height loss
Reduction in kyphotic (Cobb) angle
Improvement in quality of life scores
The search did not yield any health technology assessments on balloon kyphoplasty. The search yielded 152 citations, including those for review articles. No randomized controlled trials (RCTs) on balloon kyphoplasty were identified. All of the published studies were either prospective cohort studies or retrospective studies with no controls. Eleven studies (all case series) met the inclusion criteria. There was also a comparative study published in German that had been translated into English.
Summary of Findings
The results of the 1 comparative study (level 3a evidence) that was included in this review showed that, compared with conservative medical care, balloon kyphoplasty significantly improved patient outcomes.
Patients who had balloon kyphoplasty reported a significant reduction in pain that was maintained throughout follow-up (6 months), whereas pain scores did not change in the control group. Patients in the balloon kyphoplasty group did not need pain medication after 3 days. In the control group, about one-half of the patients needed more pain medication in the first 4 weeks after the procedure. After 6 weeks, 82% of the patients in the control group were still taking pain medication regularly.
Adjacent fractures were more frequent in the control group than in the balloon kyphoplasty group.
The case series reported on several important clinical outcomes.
Pain: Four studies on osteoporosis patients and 1 study on patients with multiple myeloma/primary cancers used the Visual Analogue Scale (VAS) to measure pain before and after balloon kyphoplasty. All of these studies reported that patients had significantly less pain after the procedure. This was maintained during follow-up. Two other studies on patients with osteoporosis also used the VAS to measure pain and found a significant improvement in pain scores; however, they did not provide follow-up data.
Vertebral body height: All 5 studies that assessed vertebral body height in patients with osteoporosis reported a significant improvement in vertebral body height after balloon kyphoplasty. One study had 1-year follow-up data for 26 patients. Vertebral body height was significantly better at 6 months and 1 year for both the anterior and midline measurements.
Two studies reported that vertebral body height was restored significantly after balloon kyphoplasty for patients with multiple myeloma or metastatic disease. In another study, the researchers reported complete height restoration in 9% of patients, a mean 56% height restoration in 60% of patients, and no appreciable height restoration in 31% of the patients who received balloon kyphoplasty.
Kyphosis correction: Four studies that assessed Cobb angle before and after balloon kyphoplasty in patients with osteoporosis found a significant reduction in degree of kyphosis after the procedure. In these studies, the differences between preoperative and postoperative Cobb angles were 3.4°, 7°, 8.8°, and 9.9°.
Only 1 study investigated kyphosis correction in patients with multiple myeloma or metastatic disease. The authors reported a significant improvement (5.2°) in local kyphosis.
Quality of life: Four studies used the Short Form 36 (SF-36) Health Survey Questionnaire to measure the quality of life in patients with osteoporosis after they had balloon kyphoplasty. A significant improvement in most of the domains of the SF-36 (bodily pain, social functioning, vitality, physical functioning, mental health, and role functioning) was observed in 2 studies. One study found that general health declined, although not significantly, and another found that role emotional declined.
Both studies that used the Oswestry Disability Index found that patients had a better quality of life after balloon kyphoplasty. In one study, this improvement was statistically significant. In another study, researchers found that quality of life after kyphoplasty improved significantly, as measured with the Roland-Morris Disability Questionnaire. Yet another study used a quality of life questionnaire and found that 62% of the patients that had balloon kyphoplasty had returned to normal activities, whereas 2 patients had reduced mobility.
To measure quality of life in patients with multiple myeloma or metastatic disease, one group of researchers used the SF-36 and found significantly better scores on bodily pain, physical functioning, vitality, and social functioning after kyphoplasty. However, the scores for general health, mental health, role physical, and role emotional had not improved. A study that used the Oswestry Disability Index reported that patients’ scores were better postoperatively and at 3 months follow-up.
These were the main findings on complications in patients with osteoporosis:
The bone cement leaked in 37 (6%) of 620 treated fractures.
There were no reports of neurological deficits.
There were no reports of pulmonary embolism due to cement leakage.
There were 6 cases of cardiovascular events in 362 patients:
3 (0.8%) patients had myocardial infarction.
3 (0.8%) patients had cardiac arrhythmias.
There was 1 (0.27%) case of pulmonary embolism due to deep venous thrombosis.
There were 20 (8.4%) cases of new fractures in 238 patients.
For patients with multiple myeloma or metastatic disease, these were the main findings:
The bone cement leaked in 12 (9.6%) of 125 procedures.
There were no reports of neurological deficits.
Economic Analysis
Balloon kyphoplasty requires anesthesia. Standard vertebroplasty requires sedation and an analgesic. Based on these considerations, the professional fees (Cdn) for each procedure is shown in Table 1.
Professional Fees for Standard Vertebroplasty and Balloon Kyphoplasty
Balloon kyphoplasty has a sizable device cost add-on of $3,578 (the device cost per case) that standard vertebroplasty does not have. Therefore, the up-front cost (i.e., physician’s fees and device costs) is $187 for standard vertebroplasty and $3,812 for balloon kyphoplasty. (All costs are in Canadian currency.)
There are also “downstream costs” of the procedures, based on the different adverse outcomes associated with each. This includes the risk of developing new fractures (21% for vertebroplasty vs. 8.4% for balloon kyphoplasty), neurological complications (3.9% for vertebroplasty vs. 0% for balloon kyphoplasty), pulmonary embolism (0.1% for vertebroplasty vs. 0% for balloon kyphoplasty), and cement leakage (26.5% for vertebroplasty vs. 6.0% for balloon kyphoplasty). Accounting for these risks, and the base costs to treat each of these complications, the expected downstream costs are estimated at less than $500 per case. Therefore, the expected total direct medical cost per patient is about $700 for standard vertebroplasty and $4,300 for balloon kyphoplasty.
Kyphon, the manufacturer of the inflatable bone tamps has stated that the predicted Canadian incidence of osteoporosis in 2005 is about 29,000. The predicted incidence of cancer-related vertebral fractures in 2005 is 6,731. Based on Ontario having about 38% of the Canadian population, the incidence in the province is likely to be about 11,000 for osteoporosis and 2,500 for cancer-related vertebral fractures. This means there could be as many as 13,500 procedures per year in Ontario; however, this is highly unlikely because most of the cancer-related fractures likely would be treated with medication. Given a $3,600 incremental direct medical cost associated with balloon kyphoplasty, the budget impact of adopting this technology could be as high as $48.6 million per year; however, based on data from the Provider Services Branch, about 120 standard vertebroplasties are done in Ontario annually. Given these current utilization patterns, the budget impact is likely to be in the range of $430,000 per year. This is because of the sizable device cost add-on of $3,578 (per case) for balloon kyphoplasty that standard vertebroplasty does not have.
Policy Considerations
Other treatments for osteoporotic VCFs are medical management and open surgery. In cases without neurological involvement, the medical treatment of osteoporotic VCFs comprises bed rest, orthotic management, and pain medication. However, these treatments are not free of side effects. Bed rest over time can result in more bone and muscle loss, and can speed the deterioration of the underlying condition. Medication can lead to altered mood or mental status. Surgery in these patients has been limited because of its inherent risks and invasiveness, and the poor quality of osteoporotic bones. However, it may be indicated in patients with neurological deficits.
Neither of these vertebral augmentation procedures eliminates the need for aggressive treatment of osteoporosis. Osteoporotic VCFs are often under-diagnosed and under-treated. A survey of physicians in Ontario (1) who treated elderly patients living in long-term care homes found that although these physicians were aware of the rates of osteoporosis in these patients, 45% did not routinely assess them for osteoporosis, and 26% did not routinely treat them for osteoporosis.
Management of the underlying condition that weakens the vertebral bodies should be part of the treatment plan. All patients with osteoporosis should be in a medical therapy program to treat the underlying condition, and the referring health care provider should monitor the clinical progress of the patient.
The main complication associated with vertebroplasty and balloon kyphoplasty is cement leakage (extravertebral or vascular). This may result in more patient morbidity, longer hospitalizations, the need for open surgery, and the use of pain medications, all of which have related costs. Extravertebral cement leakage can cause neurological complications, like spinal cord compression, nerve root compression, and radiculopathy. In some cases, surgery is required to remove the cement and release the nerve. The rate of cement leakage is much lower after balloon kyphoplasty than after vertebroplasty. Furthermore, the neurological complications seen with vertebroplasty have not seen in the studies of balloon kyphoplasty. Rarely, cement leakage into the venous system will cause a pulmonary embolism. Finally, compared with vertebroplasty, the rate of new fractures is lower after balloon kyphoplasty.
Diffusion – International, National, Provincial
In Canada, balloon kyphoplasty has not yet been funded in any of the provinces. The first balloon kyphoplasty performed in Canada was in July 2004 in Ontario.
In the United States, the technology is considered by some states as medically reasonable and necessary for the treatment of painful vertebral body compression fractures.
Conclusion
There is level 4 evidence that balloon kyphoplasty to treat pain associated with VCFs due to osteoporosis is as effective as vertebroplasty at relieving pain. Furthermore, the evidence suggests that it restores the height of the affected vertebra. It also results in lower fracture rates in other vertebrae compared with vertebroplasty, and in fewer neurological complications due to cement leakage compared with vertebroplasty. Balloon kyphoplasty is a reasonable alternative to vertebroplasty, although it must be reiterated that this conclusion is based on evidence from level 4 studies.
Balloon kyphoplasty should be restricted to facilities that have sufficient volumes to develop and maintain the expertise required to maximize good quality outcomes. Therefore, consideration should be given to limiting the number of facilities in the province that can do balloon kyphoplasty.
PMCID: PMC3387743  PMID: 23074451
5.  Are osteoporotic fractures being adequately investigated?: A questionnaire of GP & orthopaedic surgeons 
Background
To investigate the current practice of Orthopaedic Surgeons & General Practitioners (GP) when presented with patients who have a fracture, with possible underlying Osteoporosis.
Methods
Questionnaires were sent to 140 GPs and 140 Orthopaedic Surgeons. The participants were asked their routine clinical practice with regard to investigation of underlying osteoporosis in 3 clinical scenarios.
55 year old lady with a low trauma Colles fracture
60 year old lady with a vertebral wedge fracture
70 year old lady with a low trauma neck of femur fracture.
Results
Most doctors agreed that patients over 50 years old with low trauma fractures required investigation for osteoporosis, however, most surgeons (56%, n = 66) would discharge patients with low trauma Colles fracture without requesting or initiating investigation for osteoporosis. Most GPs (67%, n = 76) would not investigate a similar patient for osteoporosis, unless prompted by the Orthopaedic Surgeon or patient.
More surgeons (71%, n= 83) and GPs (64%, n = 72) would initiate investigations for osteoporosis in a vertebral wedge fracture, but few surgeons (35%, n = 23) would investigate a neck of femur fracture patient after orthopaedic treatment.
Conclusion
Most doctors know that fragility fractures in patients over 50 years old require investigation for Osteoporosis; however, a large population of patients with osteoporotic fractures are not being given the advantages of secondary prevention.
doi:10.1186/1471-2296-7-7
PMCID: PMC1388220  PMID: 16464250
6.  Closing the osteoporosis care gap – Increased osteoporosis awareness among geriatrics and rehabilitation teams 
BMC Geriatrics  2009;9:28.
Background
A care gap exists between recommendations and practice regarding the diagnosis and treatment of osteoporosis in fracture patients. The current study was designed to determine rates and predictors of in-hospital diagnosis and treatment of osteoporosis in patients admitted with fragility hip fractures, and to assess differences in these rates since the outset of the multipronged "Fracture? Think Osteoporosis" (FTOP) Program, which includes education of geriatrics and rehabilitation teams.
Methods
This is a retrospective cohort study conducted with data from two Hamilton, Ontario, university-based tertiary-care hospitals, and represents a follow-up to a previous study conducted 8 years earlier. Data pertaining to all 354 patients, age >/= 50, admitted between March 2003 and April 2004, inclusive, with a diagnosis of fragility hip fracture were evaluated. Twelve patients were excluded leaving 342 patients for analysis, with 75% female, mean age 81.
Outcomes included: Primary – In-hospital diagnosis of osteoporosis and/or initiation of anti-resorptive treatment ("new osteoporosis diagnosis/treatment"). Secondary – In-hospital mortality, BMD referrals, pre-admission osteoporosis diagnosis and treatment.
Results
At admission, 27.8% of patients had a pre-existing diagnosis of osteoporosis and/or were taking anti-resorptive treatment. Among patients with no previous osteoporosis diagnosis/treatment: 35.7% received a new diagnosis of osteoporosis, 21% were initiated on anti-resorptive treatment, and 14.3% received a BMD referral. The greatest predictor of new osteoporosis diagnosis/treatment was transfer to a rehabilitation or geriatrics unit: 79.5% of rehabilitation/geriatrics versus 18.5% of patients receiving only orthopedics care met this outcome (p < 0.001).
Conclusion
New diagnosis of osteoporosis among patients admitted with hip fracture has improved from 1.8% in the mid 1990's to 35.7%. Initiation of bisphosphonate therapy has likewise improved from 0% to 21%. Although multiple factors have likely contributed, the differential response between rehabilitation/geriatrics versus orthopedics patients suggests that education of the geriatric and rehabilitation teams, including one-on-one and group-based sessions, implemented as part of the FTOP Program, has played a role in this improvement. A significant care gap still exists for patients discharged directly from orthopedic units. The application of targeted inpatient and post-discharge initiatives, such as those that comprise the entire FTOP Program, may be of particular value in this setting.
doi:10.1186/1471-2318-9-28
PMCID: PMC2731027  PMID: 19602246
7.  Optimizing Screening for Osteoporosis in Patients With Fragility Hip Fracture 
Background
Osteoporosis, the underlying cause of most hip fractures, is underdiagnosed and undertreated. The 2008 Joint Commission report Improving and Measuring Osteoporosis Management showed only an average of 20% of patients with low-impact fracture are ever tested or treated for osteoporosis. We developed an integrated model utilizing hospitalists and orthopaedic surgeons to improve care of osteoporosis in patients with hip fracture.
Questions/purposes
Does our integrated model combining hospitalists and orthopaedic surgeons improve the frequency of evaluation for osteoporosis, screening for secondary causes, and patients’ education on osteoporosis?
Patients and Methods
Our Hospitalist-Orthopaedic Surgeon Integrated Model of Care was implemented in September 2009. We compared the rate of evaluation and treatment of osteoporosis in 140 patients admitted with fragility hip fracture at our institution before (70 patients) and after (70 patients) implementation of the care plan.
Results
Evaluation of patients for osteoporosis was higher in the postimplementation group compared to the preimplementation group (89% versus 24%). Screening of patients for secondary causes of osteoporosis was also improved in the postimplementation group (89% versus 0%), as was the proportion of patients who received education for osteoporosis management (89% versus 0%).
Conclusion
Our model of integrated care by hospitalists and orthopaedic surgeons resulted in improvement in the evaluation for osteoporosis, screening for secondary causes of osteoporosis, and education on osteoporosis management in patients with hip fracture at our institution. This may have important implications for treatment of these patients.
Level of Evidence
Level III, therapeutic study. See Guidelines for Authors for a complete description of levels of evidence.
doi:10.1007/s11999-011-1839-5
PMCID: PMC3111791  PMID: 21387105
8.  Knowledge of orthopaedic surgeons in managing patients with fragility fracture 
International Orthopaedics  2012;36(6):1275-1279.
Purpose
Fragility fractures represent a major health problem, as they cause deformity, disability and increased mortality rates. Orthopaedic surgeons should identify patients with fragility fractures and manage their osteoporosis in order to reduce the risk of future fracture; therefore, orthopaedic surgeons’ knowledge about managing fragile fracture should be evaluated.
Methods
A questionnaire was administered to 2,910 orthopaedic surgeons to address the respondents’ knowledge. The questions covered the topics of diagnosis, treatment and approach to a patient with a fragility fracture. The data-collection period for this survey spanned one year.
Results
There were 2,021 orthopaedic surgeons who participated in this study. Less than 10% of the respondents included bone mass densitometry (BMD) when evaluating patients with fragile fractures 32% prescribed proper dosage of calcium and vitamin D; approximately 30% would refer if falling from a height was suspected.
Conclusions
The majority of orthopaedic surgeons questioned lacked knowledge of fragility fracture management. This is reflected by limited knowledge of osteoporosis assessment and treatment in most areas. An appropriate method should be created to manage patients with fragility fractures to guarantee the patient the best possible care.
doi:10.1007/s00264-012-1482-0
PMCID: PMC3353064  PMID: 22281934
9.  Secondary prevention of osteoporosis in non-neck of femur fragility fractures: is it value for money? A retrospective, prospective and cross-sectional cohort study 
Background
Osteoporosis is one of the commonest bone diseases in which bone fragility is increased. Over 300,000 patients present to hospitals in the UK with fragility fractures each year, with medical and social care costs - most of which relate to hip fracture care - at around £2 billion. The number of these fractures rises by 2% a year. The 30 days mortality is 10% and 30% at 1 year. The purpose of this study is to review the current practice according to NICE and BOA guidelines of secondary prevention of osteoporosis and to suggest changes to these guidelines.
Methods
Patients over 50 years old admitted as inpatients to our facility with non-neck-of-femur (NOF) fragility fractures in March and September 2008 were studied. Retrospectively (March), looking for risk factors and if treated or not, then prospectively (September), after introducing the new trauma admission sheet. Also cross-sectional study was performed by comparing the services provided for NOF and non-NOF fragility fractures in September. Two-sample t test is used to compare between percentages.
Results
Twenty-nine percent of fragility fractures are non-NOF fractures with a mean age of 70 years, while the remaining 71% are NOF fractures with a mean age of 80 years. There is a great difference in the care provided to these patients: non-NOF fragility fractures got less attention for assessment of osteoporosis (25%) and obtained less interest in investigations by medical staff (11%) and, finally, less intentions to treat osteoporosis (35%), compared to NOF fractures in which 35% of cases were assessed, 47% were investigated and 71% were treated for osteoporosis. Twenty-five percent of NOF fracture patients were found to have previous fragility fractures in the preceding years, while only 6% were on osteoporosis treatment before the fracture.
Conclusion
Osteoporosis (a new epidemic) is the most common disease of the bone and its incidence is rising rapidly as the population ages. Though treatable, it is often left untreated. We believe that treating patients with non-NOF fragility fractures from osteoporosis before proceeding to NOF fractures would improve their quality of life and reduce the burden on hospital services and funding.
doi:10.1186/1749-799X-8-44
PMCID: PMC4222047  PMID: 24289492
Fragility fractures; Bisphosphonates; Osteoporosis; Non-NOF fractures; DEXA; NICE guidelines
10.  Surgeon Specialty Influences Referral Rate for Osteoporosis Management following Vertebral Compression Fractures 
Global Spine Journal  2015;6(6):524-528.
Study Design
 Retrospective chart review.
Objective
 To evaluate the referral rate for long-term osteoporosis management following vertebral compression fracture treated by different specialties at a single academic institution.
Methods
 Patients undergoing vertebral cement augmentation for painful osteoporotic compression fractures from 2009 to 2014 were identified. Medical records were reviewed to determine if the treating surgeon discussed and/or referred the patient for long-term osteoporosis management. Any referral for or mention of medical long-term osteoporosis management was counted as a positive response. Results were statistically analyzed with chi-square test.
Results
 Two hundred fourteen patients underwent vertebral cement augmentation; 150 met inclusion criteria. Orthopedic surgeons treated 88 patients, neurosurgeons treated 39, and interventional radiology or pain management physicians treated 23. Orthopedic surgeons referred 82% of patients for osteoporosis management, neurosurgeons referred 36%, and interventional radiology/pain management referred 17%. The referral rate was significantly higher for orthopedic surgeons compared with either of the other two groups; there was no significant difference between neurosurgery and interventional radiology/pain management.
Conclusions
 Among physicians who treat osteoporotic vertebral compression fractures, orthopedic surgeons more frequently address osteoporosis or refer patients for osteoporosis management compared with neurosurgeons and interventional radiologists or pain management physicians. The results of this study shed light on the disparity in how different specialties approach treatment of osteoporosis in patients with fractures painful enough to require surgery and highlight potential areas for improvement in osteoporosis awareness training.
doi:10.1055/s-0035-1569057
PMCID: PMC4993620  PMID: 27555992
vertebral compression fractures; vertebroplasty; kyphoplasty; osteoporosis; interspecialty referral rate; osteoporosis treatment
11.  Working toward reducing postoperative fracture radiographs: a survey of Canadian surgeons 
Canadian Journal of Surgery  2016;59(1):26-28.
Background
When fracture management includes operative fixation with a load-sharing construct in good-quality bone, screening for healing problems or hardware failure with radiographs in the first 6 postoperative weeks may be unnecessary. I sought to determine Canadian orthopedic surgeons’ current protocol for early postoperative radiographs of stable, internally fixed fractures as well as their willingness to adopt a simplified protocol.
Methods
Members of the Canadian Orthopaedic Association were surveyed electronically. Five examples of surgically treated fractures were chosen to represent the spectrum of load-sharing constructs. The survey collected demographic data and inquired about current postoperative radiograph protocols and consideration of a simplified protocol.
Results
Of the 822 emailed invitations to complete the survey, 400 were opened and 243 surveys were completed. Most participants (91%) practised in Canada and managed some trauma (91%), but were not trauma specialists (82%). Surgeon experience was equally distributed. Sixty-six percent of respondents acquire immediate postoperative radiographs after femur and tibia intramedullary nails, and 62% repeat radiographs at 2-week follow-up. Fifty-one percent of respondents acquire immediate postoperative radiographs after forearm, humerus and ankle internal fixation, and 69% repeat radiographs at 2-week follow-up. Of the respondents who currently acquire radiographs, 33% would consider foregoing immediate postoperative radiographs after intramedullary nailing of femur and tibia fractures, while 25% would forego them at 2-week follow-up. Similarly, 58% would consider foregoing radiographs immediately after internal fixation of forearm, humerus and ankle fractures, while 24% would forego them at 2-week follow-up.
Conclusion
Many Canadian orthopedic surgeons do not acquire screening postoperative radiographs after stable fracture fixation, and many more are willing to adopt this practice. These findings support investigating the safety and cost-effectiveness of a simplified postoperative radiographic protocol.
doi:10.1503/cjs.005715
PMCID: PMC4734915  PMID: 26812405
12.  The osteoporosis care gap in Canada 
Background
The presence of a fragility fracture is a major risk factor for osteoporosis, and should be an indicator for osteoporosis diagnosis and therapy. However, the extent to which patients who fracture are assessed and treated for osteoporosis is not clear.
Methods
We performed a review of the literature to identify the practice patterns in the diagnosis and treatment of osteoporosis in adults over the age of 40 who experience a fragility fracture in Canada. Searches were performed in MEDLINE (1966 to January 2, 2003) and CINAHL (1982 to February 1, 2003) databases.
Results
There is evidence of a care gap between the occurrence of a fragility fracture and the diagnosis and treatment of osteoporosis in Canada. The proportion of individuals with a fragility fracture who received an osteoporosis diagnostic test or physician diagnosis ranged from 1.7% to 50%. Therapies such as hormone replacement therapy, bisphosphonates or calcitonin were being prescribed to 5.2% to 37.5% of patients. Calcium and vitamin D supplement intake was variable, and ranged between 2.8% to 61.6% of patients.
Conclusion
Many Canadians who experience fragility fracture are not receiving osteoporosis management for the prevention of future fractures.
doi:10.1186/1471-2474-5-11
PMCID: PMC420244  PMID: 15068488
osteoporosis; fracture; Canada; diagnosis; treatment
13.  Fracture risk assessment in long-term care: a survey of long-term care physicians 
BMC Geriatrics  2013;13:109.
Background
The majority of frail elderly who live in long-term care (LTC) are not treated for osteoporosis despite their high risk for fragility fractures. Clinical Practice Guidelines for the diagnosis and management of osteoporosis provide guidance for the management of individuals 50 years and older at risk for fractures, however, they cannot benefit LTC residents if physicians perceive barriers to their application. Our objectives are to explore current practices to fracture risk assessment by LTC physicians and describe barriers to applying the recently published Osteoporosis Canada practice guidelines for fracture assessment and prevention in LTC.
Methods
A cross-sectional survey was conducted with the Ontario Long-Term Care Physicians Association using an online questionnaire. The survey included questions that addressed members’ attitudes, knowledge, and behaviour with respect to fracture risk assessment in LTC. Closed-ended responses were analyzed using descriptive statistics and thematic framework analysis for open-ended responses.
Results
We contacted 347 LTC physicians; 25% submitted completed surveys (81% men, mean age 60 (Standard Deviation [SD] 11) years, average 32 [SD 11] years in practice). Of the surveyed physicians, 87% considered prevention of fragility fractures to be important, but a minority (34%) reported using validated fracture risk assessment tools, while 33% did not use any. Clinical risk factors recommended by the OC guidelines for assessing fracture risk considered applicable included; glucocorticoid use (99%), fall history (93%), age (92%), and fracture history (91%). Recommended clinical measurements considered applicable included: weight (84%), thyroid-stimulating hormone (78%) and creatinine (73%) measurements, height (61%), and Get-Up-and-Go test (60%). Perceived barriers to assessing fracture risk included difficulty acquiring necessary information, lack of access to tests (bone mineral density, x-rays) or obtaining medical history; resource constraints, and a sentiment that assessing fracture risk is futile in this population because of short life expectancy and polypharmacy.
Conclusion
Perceived barriers to fracture risk assessment and osteoporosis management in LTC have not changed recently, contributing in part to the ongoing care gap in osteoporosis management. Our findings highlight the importance to adapt guidelines to be applicable to the LTC environment, and to develop partnerships with stakeholders to facilitate their use in clinical practice.
doi:10.1186/1471-2318-13-109
PMCID: PMC3853074  PMID: 24138565
Fractures; Osteoporosis; Fracture risk assessment; Long-term care; Survey
14.  Current Practices Regarding Perioperative Management of Patients With Fracture on Antiplatelet Therapy 
Objective:
There continues to be controversy over whether operative delay is necessary for patients on antiplatelet therapy, particularly for elderly patients with hip fractures. This study sought to assess current clinical practices of orthopedic surgeons regarding perioperative management of these patients.
Methods:
A 12-question, Web-based survey was distributed to orthopedic surgeons via e-mail. Questions regarding timing of surgery assumed patients were on antiplatelet therapy and assessed attitudes toward emergent and nonemergent orthopedic cases as well as operative delay for specific closed fracture types. Responses were compared using unpaired, 2-tailed Student t tests for continuous variables and Pearson chi-square tests with odds ratios (ORs) and 95% confidence intervals (CIs) for categorical variables. Statistical significance was defined as a P value <.05.
Results:
Overall 67 orthopedic surgeons responded. Fifty-two percent (n = 35) of the respondents described their practice as academic. Thirty-nine percent (n = 25) of the surgeons indicated that no delay was acceptable for urgent but nonemergent surgery, and 78% (n = 50) reported no delay for emergent surgery was acceptable. Sixty-eight percent (n = 46) of respondents felt patients on antiplatelet therapy with closed hip fractures did not require operative delay. Surgeons who opted for surgical delay in hip fractures were more likely to delay surgery in other lower extremity fracture types (OR = 16.4, 95% CI 4.48-60.61, P < .001). Sixty-four percent (n = 41) of the surgeons indicated there was no protocol in place at their institution.
Conclusions:
There continues to be wide variability among orthopedic surgeons with regard to management of patients with fracture on antiplatelet therapy. Over a quarter of surgeons continue to opt for surgical delay in patients with hip fracture. This survey highlights the need to formulate and better disseminate practice management guidelines for patients with fracture on antiplatelet therapy, particularly given the aging population in the United States.
doi:10.1177/2151458515605156
PMCID: PMC4647196  PMID: 26623164
geriatric trauma; fragility fractures; antiplatelet therapy; hip fracture; orthopedics; clopidogrel; operative delay
15.  The NYU Osteoporosis Model of Care Experience 
Introduction:
Participants who sustain a fragility fracture are at increased risk for subsequent fractures. Despite the consequences of recurrent fractures, bone mineral density (BMD) testing and treatment rates for osteoporosis after a fracture remain low. The New York University (NYU) Langone Osteoporosis Model of Care was developed to identify women at increased risk for recurrent fractures and to reduce the rates of subsequent fracture through patient and physician education.
Methods:
Women aged 50 years and older who had a fracture and received their care at NYU affiliated hospitals were contacted via mail after discharge. Participants were provided educational materials explaining decreased bone strength and its possible relationship to their fracture and were asked to complete a questionnaire. One year postfracture, participants were sent follow-up questionnaires requesting their most recent fracture treatment and BMD information. Educational material was also provided to the treating orthopedic surgeons.
Results:
Overall, 524 patients were contacted and 210 (40%) enrolled. By the end of 24 months, 92 participants completed their 1-year questionnaire (44% of the enrollees). Forty-two (46%) participants had undergone new BMD testing and 37 (40%) were receiving antiresorptive medications, including 6 (6%) who had not been prescribed these medications before enrolling in the program.
Conclusions:
The Osteoporosis Model of Care is a simple and cost-effective educational program, which improved comprehensive fracture care in an actual clinical setting. Patient enrollment remains a challenge in implementing the program. Our program highlights difficulties in providing community-dwelling participants with appropriate postfracture care. With increasing concern among the public regarding the use of bone strengthening medications and continued low postfracture treatment rates, educating patients with high fracture risk is critical to reducing the rate of subsequent fracture. Our Model of Care Program demonstrates both the success and limitations of a postfracture educational approach using discharge diagnosis data to identify patients with fracture.
doi:10.1177/2151458515604358
PMCID: PMC4647193  PMID: 26623162
osteoporosis; bone mineral density; fragility fracture; bone strengthening medication; fracture prevention program
16.  The osteoporosis care gap in men with fragility fractures: the Canadian Multicentre Osteoporosis Study 
Summary
We examined osteoporosis diagnosis/treatment in 2,187 community dwelling men age 50+. After five years in the study, 90% of men with fragility fractures remained undiagnosed and untreated for osteoporosis. The need to treat fragility fractures is well established in guidelines, and these numbers represent an important care gap.
Introduction
Whether physicians in the community are recognizing and appropriately treating osteoporosis and fragility fractures in men remains unknown. We examined the rate of diagnosis and treatment in community dwelling men participating in the Canadian Multicentre Osteoporosis Study (CaMos).
Methods
Between February 1996 and September 2002, 2,187 participants were recruited from nine sites across Canada and prospectively followed. Information on osteoporosis diagnosis, fractures, medications were collected annually by a detailed questionnaire. DXA examination of lumbar spine (L1-4) and hip were conducted at baseline and year five.
Results
Diagnosis and treatment in men with clinical fragility fractures was low: at baseline and year five only 2.3% and 10.3% of men with a clinical fracture reported an osteoporosis diagnosis, respectively. At year five, 90% of men with a clinical fragility fracture were untreated. Hip fractures were the most commonly treated (37.5% by year five). A diagnosis of osteoporosis resulted in greater treatment: 67% of participants with diagnosed osteoporosis were treated with a bisphosphonate and 87% were taking calcium and/or vitamin D (year five).
Conclusions
In this population-based study, both a diagnostic and therapeutic gap existed between knowledge and practice related to fragility fractures and osteoporosis in men aged ≥50 years.
doi:10.1007/s00198-007-0483-0
PMCID: PMC5104547  PMID: 17924051 CAMSID: cams6236
Bisphosphonate; Care gap; Diagnosis; Fractures; Males; Osteoporosis
17.  Minimizing Disparities in Osteoporosis Care of Minorities With an Electronic Medical Record Care Plan 
Background
Ethnic disparities in care have been documented with a number of musculoskeletal disorders including osteoporosis. We suggest a systems approach for ensuring osteoporosis care can minimize potential ethnic disparities in care.
Questions/purposes
We evaluated variations in osteoporosis treatment by age, sex, and race/ethnicity by (1) measuring the rates of patients after a fragility fracture who had been evaluated by dual-energy xray absorptiometry and/or in whom antiosteoporosis treatment had been initiated and (2) determining the rates of osteoporosis treatment in patients who subsequently had a hip fracture.
Patients and Methods
We implemented an integrated osteoporosis prevention program in a large health plan. Continuous screening of electronic medical records identified patients who met the criteria for screening for osteoporosis, were diagnosed with osteoporosis, or sustained a fragility fracture. At-risk patients were referred to care managers and providers to complete practice guidelines to close care gaps. Race/ethnicity was self-reported. Treatment rates after fragility fracture or osteoporosis treatment failures with later hip fracture were calculated. Data for the years 2008 to 2009 were stratified by age, sex, and race/ethnicity.
Results
Women (92.1%) were treated more often than men (75.2%) after index fragility fracture. The treatment rate after fragility fracture was similar among race/ethnic groups in either sex (women 87.4%–93.4% and men 69.3%–76.7%). Osteoporotic treatment before hip fracture was more likely in white men and women and Hispanic men than other race/ethnic and gender groups.
Conclusions
Racial variation in osteoporosis care after fragility fracture in race/ethnic groups in this healthcare system was low when using the electronic medical record identifying care gaps, with continued reminders to osteoporosis disease management care managers and providers until those care gaps were closed.
doi:10.1007/s11999-011-1852-8
PMCID: PMC3111780  PMID: 21424836
18.  Fracture prevention service to bridge the osteoporosis care gap 
Clinical Interventions in Aging  2015;10:1035-1042.
Background
A care gap exists between the health care needs of older persons with fragility fractures and the therapeutic answers they receive. The Fracture Prevention Service (FPS), a tailored in-hospital model of care, may effectively bridge the osteoporosis care gap for hip-fractured older persons. The purpose of this study was to evaluate the efficacy of the FPS in targeting persons at high risk of future fracture and to improve their adherence to treatment.
Methods
This was a prospective observational study conducted in a teaching hospital with traumatology and geriatric units, and had a pre-intervention and post-intervention phase. The records of 172 participants were evaluated in the pre-intervention phase, while data from 210 participants were gathered in the post-intervention phase. All participants underwent telephone follow-up at 12 months after hospital discharge. The participants were patients aged ≥65 years admitted to the orthopedic acute ward who underwent surgical repair of a proximal femoral fracture. A multidisciplinary integrated model of care was established. Dedicated pathways were implemented in clinical practice to optimize the identification of high-risk persons, improve their evaluation through bone mineral density testing and blood examinations, and initiate an appropriate treatment for secondary prevention of falls and fragility fractures.
Results
Compared with the pre-intervention phase, more hip-fractured persons received bone mineral density testing (47.62% versus 14.53%, P<0.0001), specific pharmacological treatments (48.51% versus 17.16%, P<0.0001), and an appointment for evaluation at a fall and fracture clinic (52.48% versus 2.37%, P<0.0001) in the post-intervention phase. Independent of some confounders, implementation of the FPS was positively associated with recommendations for secondary fracture prevention at discharge (P<0.0001) and with 1-year adherence to pharmacological treatment (P<0.0001).
Conclusion
The FPS is an effective multidisciplinary integrated model of care to optimize identification of older persons at highest risk for fragility fracture, to improve their clinical management, and to increase adherence to prescriptions.
doi:10.2147/CIA.S76695
PMCID: PMC4485792  PMID: 26150707
osteoporosis; secondary prevention; hip fracture; fracture liaison service; model of care
19.  Established Osteoporosis and Gaps in the Management: Review from a Teaching hospital 
Background:
International osteoporosis foundation described severe or established osteoporosis as an osteoporotic individual with a fragility fracture. Orthopaedic surgeons frequently manage fractures, but we believe that large gaps are prevalent in the medical management of osteoporosis after fractures are fixed.
Aim:
The aim of this analysis is to assess the investigations and gaps in the management of osteoporosis in patients admitted with a fragility fracture of femur at King Fahd Hospital of the University, AlKhobar, Saudi Arabia.
Materials and Methods:
A retrospective analysis of all admission and discharge; medical and pharmacy records database of patients over ≥ 50 years with fragility fracture between January 2001 and December 2011. The outcome measures assessed were investigations such as serum calcium, phosphorous, alkaline phosphatase, parathormone, 25 hydroxy vitamin D (25OHD) levels and a dual energy X-ray absorptiometry (DEXA). Secondly once the fracture was fixed what medications were prescribed, calcium and vitamin D, antiresorptives and anabolic agents.
Results:
There were 207 patients admitted during the study period with an average age of 69.2 (12.1) years and 118 were females. In 169 (81.6%) patients, the fracture site was proximal femur. Vitamin D (25OHD) was requested in 31/207 (14.9%). DEXA scan was ordered in 49/207 (24.1%). A total of 78/207 (37.6%) patients received calcium and vitamin D3 and 94/207 (45.4%) either got calcium or vitamin D3. Bisphosphonates was used in 35, miacalcic nasal spray in 25 and anabolic agent teriparatide was prescribed in 21 patients. Post-fixation 126/207 (60.8%) patients did not receive any anti-osteoporotic medication. In untreated group, there were 87 males and 39 females.
Conclusions:
The study found that in patients, who sustained a fragility fracture, confirmation of osteoporosis by DEXA was very low and ideal treatment for severe osteoporosis was given out to few patients. More efforts are needed to fill this large gap in the correct management of osteoporosis related fractures by orthopaedic surgeons.
doi:10.4103/2141-9248.129038
PMCID: PMC3991939  PMID: 24761237
Fragility fractures; Management; Osteoporosis; Saudi Arabia
20.  A National Fragility Fractures Register 
In Italy, osteoporosis is a disease potentially affecting five million people, 80% of whom are post-menopausal women. The natural history of this disease culminates, dramatically, in fragility fractures. The incidence of fragility fractures is now reaching epidemic proportions and, indeed, can no longer be underestimated. In Italy, epidemiological data can be derived only from hospital discharge record (HDR)-based statistics supplied by the Ministry of Health. Since these records contain data relating only to patients discharged from hospitals and institutes providing inpatient care, they provide a figure much lower than the estimated 280,000+ new fractures every year. Despite the availability of these instruments, statistics on hospital admissions may be deemed reliable only in relation to the number of hip fractures, which in 2007 led to over 90,000 hospitalisations. Fragility fractures of other skeletal districts, on the other hand, are often treated non-invasively in the ER and therefore “slip through” the HDR net, leading to an absence of relative data, both as regards numbers and diagnoses. Data collected using the HDR system, which records information on the principal diagnosis (the reason treatment was needed and diagnostic investigations performed) and on secondary diagnoses (coexisting conditions at the time of hospital admission), constitute a resource for studying, assessing and planning admissions. This information, coded using the International Classification of Diseases 9 (ICD 9), is transmitted to regional authorities and then, by them, to the Ministry of Health. The ICD 9 classification is based on two main criteria: one is aetiological (the cause of the fracture) and the other anatomical (the site of the fracture); the latter is the one used most. In the case of fragility fractures, the presence of osteoporosis can be signalled only as a secondary diagnosis, thereby minimising its role in their pathogenesis. From this perspective, the limits of the classification system influence the definition of the real extent of fractures linked to bone fragility, therefore resulting in underestimation of the phenomenon. This separation of the fracture event from the diagnosis of osteoporosis means that the patient does not receive adequate treatment for the underlying disease.
In an attempt to resolve these problems, Italy’s present health minister, Ferruccio Fazio, on the occasion of the World Osteoporosis Day (October 20, 2009), unveiled a project to set up, with the collaboration of the Italian regions, a national fragility fracture register (NFFR), the only one in the world. Registers of this kind are instruments for the systematic collection, nationally, of the data needed to analyse the efficiency of processes and methods involved in health service provision to citizens. The NFFR will collect: demographic data, “process” outcomes (days of hospitalisation, treatments, timing of surgery, complications, types of discharge, etc.) and “final” outcomes (mortality, residual pain, functional recovery, residual disability, etc.). The data will be drawn from the HDRs of ordinary inpatient departments, from ER HDRs, from analyses of local health authority databases, and possibly from subsequent outcome surveys of quality of life and residual disability. There are plans to create a national data collection centre, to be run and coordinated by the Health Ministry, into which will be entered data from the regional registries. In this context, the aim of the NFFR is to establish the quality of interventions at regional and national level, to compare different local settings and identify areas where there is room for improvement in health service delivery, and to define reference standards of care, ranging from optimal to minimum acceptable standards. The NFFR will make it possible to establish more clearly the real extent of the problem and of its social and economic impact, allowing conditions of skeletal fragility to be reported, and thus adequately assessed and treated. The assigning of each individual patient with an alphanumerical code will be useful in the event of further interventions or re-fractures and for the creation of a risk card, a single unified card for collecting a patient’s history, that will be a further useful instrument for defining an individual’s bone fragility status. These further data could usefully complete the data collected in the NFFR, thereby improving the approach to and management of the multifaceted problem of fragile bones. It is necessary to promote a multidisciplinary approach to the patient, as well as the creation of “fragility fracture units”, an organisational model based on a pathway ensuring constant synergy between the different specialties involved in the care of the fracture patient. The NFFR will allow monitoring of the fragility fracture phenomenon so as to rationalise resources and monitor the efficacy of health policy interventions.
PMCID: PMC3213778
21.  The Fracture Unit Concept 
The “fracture unit” is one of the possible ground-breaking responses to the health needs of our country’s growing elderly population, its aim being to achieve effective and efficient management of osteoporosis-induced fractures (mainly hip and vertebral, but also rib, radial, tibial and tarsal fractures), whose incidence peaks in the over-65s. The “fracture unit” concept is based on the principle of optimising, through a collaborative approach, the organisational frameworks of the different specialties involved in the management of the fracture patient (old or young, presenting serious risk factors for osteoporosis), simply by creating structured pathways that facilitate the establishment of stable synergies between the different specialists and shared protocols, specific for the different types of fracture. This model, based on the integration of different disciplinary sectors, is already used successfully in other specialist medical areas; furthermore, transverse integration of different care functions, on the basis of similarities defined by their common clinical objectives, is deemed feasible by current national and regional management guidelines. An “Integrated Functional Unit for Fragility Fractures” (fracture unit) could be created by intervening on a purely organisational level on existing structures, without the need to “invent” anything new and, above all, without generating costs.
The objective is thus to define and structure, a priori, a multidisciplinary pathway into which the patient with a fracture, on coming into contact with the healthcare provider, is automatically slotted. The patient’s case is thus taken on by the “fracture unit” to which he or she has been referred by the emergency department, by other inpatient services (residential or long-term inpatient facilities, etc.) or, from the local area, by general practitioners or specialist outpatient departments. In a structured pathway of this kind, in which different specialists are involved, the patient will no longer be the object of requests for consultations made at the discretion of the single duty physician, nor will he be “left to himself” following his or her discharge from hospital. Indeed, if it is essential to favour synergies within the context of the hospital care pathway, it is equally important to define a similar structured pathway of care for the patient also in the post-acute phase, i.e. to guarantee that the case is taken on by the local providers of social and healthcare services (particularly for rehabilitation and the supply of aids, prostheses or simple hip protectors) and by GPs, whose task it must be to reassess patients continually, monitoring their “compliance” with therapies and with the programme of specialist checkups.
To make a fracture unit fully operational it is necessary to pursue several organisational objectives: involvement of the emergency department, identification of the single specialists involved, definition of the diagnostic pathways and clinical protocols, creation of a team to be responsible for quality control of the care provided, for guaranteeing the necessary scientific updating, and for ensuring smooth links with local healthcare providers for patient follow up.
The fracture unit models already tested in other countries have been found to have a positive effect that can be measured in terms of reduced post-fracture complications, reduced mortality, shorter hospital stays and less need for further hospitalisations. Specifically, the adoption of a “fracture unit” model made it possible to reduce major complications (such as cognitive decline, bedsores, deep vein thrombosis and respiratory or cardio-circulatory complications) by between 21% and 45%, whereas hospital re-admissions at six months were reduced by 20% and mortality by 3%. In addition to the obvious health benefits, positive economic effects in terms of consumption of resources can be expected, deriving from the reduction in complications and re-admissions to hospital. It thus amounts to optimisation of efficacy and efficiency, but also a drive to achieve more equal access to care and rehabilitation treatments. Indeed, activation of the “fracture unit” model should mean integration of the available services within a single hospital or “presidio ospedaliero ASL”. Logistically, this means that all the services are localised within the same hospital, but in sites separate from the orthopaedics/traumatology department to which the fragility fracture patient is admitted, reflecting the departmental organisation already provided for by current regulations.
PMCID: PMC3213822
22.  Venting during prophylactic nailing for femoral metastases: current orthopedic practice 
Canadian Journal of Surgery  2003;46(6):427-431.
Introduction
Reamed intramedullary nailing, recommended for impending fracture of a femur weakened by bone metastases, causes a rise in intramedullary pressure and increases the risk of a fat embolism syndrome. The pressure can be equalized by the technique of venting — drilling a hole into the distal cortex of the femur. Our objective was to study the current practice of orthopedic surgeons in Ontario with respect to venting during prophylactic intramedullary nailing for an impending femoral fracture due to bone metastases.
Methods
We mailed a questionnaire to all orthopedic surgeons from the Province of Ontario listed in the 1999 Canadian Medical Directory or on the Canadian Orthopaedic Association membership list, asking if they vent when prophylactically nailing an impending pathologic femoral fracture. The responses were modelled as a function of surgeon volume and year of graduation.
Results
Of the 415 surveys mailed, 223 (54%) surgeons responded. Of these, 81% reported having prophylactically treated a femoral metastatic lesion during the previous year; 67% treated 1 to 3 metastatic lesions and 14% treated more than 3; 19% did not treat a metastatic femoral lesion prophylactically. Over two-thirds of surgeons had never considered venting, whereas one-third always or sometimes vented the femoral canal. More recent graduates were 3 times more likely to vent than earlier (before 1980) graduates (odds ratio [OR] = 3.2, 95% confidence interval [CI] 1.6–6.5) as were those who treat a greater number of impending fractures (OR = 1.4, 95% CI 1.1–1.7).
Conclusions
Although there is a theoretical rationale for routine venting, there is disagreement among Ontario orthopedic surgeons regarding the use of this technique during prophylactic nailing for femoral metastatic lesions. Prospective evidence will be required to warrant a change in the standard of care.
PMCID: PMC3211767  PMID: 14680349
23.  Clinical Utility of Vitamin D Testing 
Executive Summary
This report from the Medical Advisory Secretariat (MAS) was intended to evaluate the clinical utility of vitamin D testing in average risk Canadians and in those with kidney disease. As a separate analysis, this report also includes a systematic literature review of the prevalence of vitamin D deficiency in these two subgroups.
This evaluation did not set out to determine the serum vitamin D thresholds that might apply to non-bone health outcomes. For bone health outcomes, no high or moderate quality evidence could be found to support a target serum level above 50 nmol/L. Similarly, no high or moderate quality evidence could be found to support vitamin D’s effects in non-bone health outcomes, other than falls.
Vitamin D
Vitamin D is a lipid soluble vitamin that acts as a hormone. It stimulates intestinal calcium absorption and is important in maintaining adequate phosphate levels for bone mineralization, bone growth, and remodelling. It’s also believed to be involved in the regulation of cell growth proliferation and apoptosis (programmed cell death), as well as modulation of the immune system and other functions. Alone or in combination with calcium, Vitamin D has also been shown to reduce the risk of fractures in elderly men (≥ 65 years), postmenopausal women, and the risk of falls in community-dwelling seniors. However, in a comprehensive systematic review, inconsistent results were found concerning the effects of vitamin D in conditions such as cancer, all-cause mortality, and cardiovascular disease. In fact, no high or moderate quality evidence could be found concerning the effects of vitamin D in such non-bone health outcomes. Given the uncertainties surrounding the effects of vitamin D in non-bone health related outcomes, it was decided that this evaluation should focus on falls and the effects of vitamin D in bone health and exclusively within average-risk individuals and patients with kidney disease.
Synthesis of vitamin D occurs naturally in the skin through exposure to ultraviolet B (UVB) radiation from sunlight, but it can also be obtained from dietary sources including fortified foods, and supplements. Foods rich in vitamin D include fatty fish, egg yolks, fish liver oil, and some types of mushrooms. Since it is usually difficult to obtain sufficient vitamin D from non-fortified foods, either due to low content or infrequent use, most vitamin D is obtained from fortified foods, exposure to sunlight, and supplements.
Clinical Need: Condition and Target Population
Vitamin D deficiency may lead to rickets in infants and osteomalacia in adults. Factors believed to be associated with vitamin D deficiency include:
darker skin pigmentation,
winter season,
living at higher latitudes,
skin coverage,
kidney disease,
malabsorption syndromes such as Crohn’s disease, cystic fibrosis, and
genetic factors.
Patients with chronic kidney disease (CKD) are at a higher risk of vitamin D deficiency due to either renal losses or decreased synthesis of 1,25-dihydroxyvitamin D.
Health Canada currently recommends that, until the daily recommended intakes (DRI) for vitamin D are updated, Canada’s Food Guide (Eating Well with Canada’s Food Guide) should be followed with respect to vitamin D intake. Issued in 2007, the Guide recommends that Canadians consume two cups (500 ml) of fortified milk or fortified soy beverages daily in order to obtain a daily intake of 200 IU. In addition, men and women over the age of 50 should take 400 IU of vitamin D supplements daily. Additional recommendations were made for breastfed infants.
A Canadian survey evaluated the median vitamin D intake derived from diet alone (excluding supplements) among 35,000 Canadians, 10,900 of which were from Ontario. Among Ontarian males ages 9 and up, the median daily dietary vitamin D intake ranged between 196 IU and 272 IU per day. Among females, it varied from 152 IU to 196 IU per day. In boys and girls ages 1 to 3, the median daily dietary vitamin D intake was 248 IU, while among those 4 to 8 years it was 224 IU.
Vitamin D Testing
Two laboratory tests for vitamin D are available, 25-hydroxy vitamin D, referred to as 25(OH)D, and 1,25-dihydroxyvitamin D. Vitamin D status is assessed by measuring the serum 25(OH)D levels, which can be assayed using radioimmunoassays, competitive protein-binding assays (CPBA), high pressure liquid chromatography (HPLC), and liquid chromatography-tandem mass spectrometry (LC-MS/MS). These may yield different results with inter-assay variation reaching up to 25% (at lower serum levels) and intra-assay variation reaching 10%.
The optimal serum concentration of vitamin D has not been established and it may change across different stages of life. Similarly, there is currently no consensus on target serum vitamin D levels. There does, however, appear to be a consensus on the definition of vitamin D deficiency at 25(OH)D < 25 nmol/l, which is based on the risk of diseases such as rickets and osteomalacia. Higher target serum levels have also been proposed based on subclinical endpoints such as parathyroid hormone (PTH). Therefore, in this report, two conservative target serum levels have been adopted, 25 nmol/L (based on the risk of rickets and osteomalacia), and 40 to 50 nmol/L (based on vitamin D’s interaction with PTH).
Ontario Context
Volume & Cost
The volume of vitamin D tests done in Ontario has been increasing over the past 5 years with a steep increase of 169,000 tests in 2007 to more than 393,400 tests in 2008. The number of tests continues to rise with the projected number of tests for 2009 exceeding 731,000. According to the Ontario Schedule of Benefits, the billing cost of each test is $51.7 for 25(OH)D (L606, 100 LMS units, $0.517/unit) and $77.6 for 1,25-dihydroxyvitamin D (L605, 150 LMS units, $0.517/unit). Province wide, the total annual cost of vitamin D testing has increased from approximately $1.7M in 2004 to over $21.0M in 2008. The projected annual cost for 2009 is approximately $38.8M.
Evidence-Based Analysis
The objective of this report is to evaluate the clinical utility of vitamin D testing in the average risk population and in those with kidney disease. As a separate analysis, the report also sought to evaluate the prevalence of vitamin D deficiency in Canada. The specific research questions addressed were thus:
What is the clinical utility of vitamin D testing in the average risk population and in subjects with kidney disease?
What is the prevalence of vitamin D deficiency in the average risk population in Canada?
What is the prevalence of vitamin D deficiency in patients with kidney disease in Canada?
Clinical utility was defined as the ability to improve bone health outcomes with the focus on the average risk population (excluding those with osteoporosis) and patients with kidney disease.
Literature Search
A literature search was performed on July 17th, 2009 using OVID MEDLINE, MEDLINE In-Process and Other Non-Indexed Citations, EMBASE, the Cumulative Index to Nursing & Allied Health Literature (CINAHL), the Cochrane Library, and the International Agency for Health Technology Assessment (INAHTA) for studies published from January 1, 1998 until July 17th, 2009. Abstracts were reviewed by a single reviewer and, for those studies meeting the eligibility criteria, full-text articles were obtained. Reference lists were also examined for any additional relevant studies not identified through the search. Articles with unknown eligibility were reviewed with a second clinical epidemiologist, then a group of epidemiologists until consensus was established. The quality of evidence was assessed as high, moderate, low or very low according to GRADE methodology.
Observational studies that evaluated the prevalence of vitamin D deficiency in Canada in the population of interest were included based on the inclusion and exclusion criteria listed below. The baseline values were used in this report in the case of interventional studies that evaluated the effect of vitamin D intake on serum levels. Studies published in grey literature were included if no studies published in the peer-reviewed literature were identified for specific outcomes or subgroups.
Considering that vitamin D status may be affected by factors such as latitude, sun exposure, food fortification, among others, the search focused on prevalence studies published in Canada. In cases where no Canadian prevalence studies were identified, the decision was made to include studies from the United States, given the similar policies in vitamin D food fortification and recommended daily intake.
Inclusion Criteria
Studies published in English
Publications that reported the prevalence of vitamin D deficiency in Canada
Studies that included subjects from the general population or with kidney disease
Studies in children or adults
Studies published between January 1998 and July 17th 2009
Exclusion Criteria
Studies that included subjects defined according to a specific disease other than kidney disease
Letters, comments, and editorials
Studies that measured the serum vitamin D levels but did not report the percentage of subjects with serum levels below a given threshold
Outcomes of Interest
Prevalence of serum vitamin D less than 25 nmol/L
Prevalence of serum vitamin D less than 40 to 50 nmol/L
Serum 25-hydroxyvitamin D was the metabolite used to assess vitamin D status. Results from adult and children studies were reported separately. Subgroup analyses according to factors that affect serum vitamin D levels (e.g., seasonal effects, skin pigmentation, and vitamin D intake) were reported if enough information was provided in the studies
Quality of Evidence
The quality of the prevalence studies was based on the method of subject recruitment and sampling, possibility of selection bias, and generalizability to the source population. The overall quality of the trials was examined according to the GRADE Working Group criteria.
Summary of Findings
Fourteen prevalence studies examining Canadian adults and children met the eligibility criteria. With the exception of one longitudinal study, the studies had a cross-sectional design. Two studies were conducted among Canadian adults with renal disease but none studied Canadian children with renal disease (though three such US studies were included). No systematic reviews or health technology assessments that evaluated the prevalence of vitamin D deficiency in Canada were identified. Two studies were published in grey literature, consisting of a Canadian survey designed to measure serum vitamin D levels and a study in infants presented as an abstract at a conference. Also included were the results of vitamin D tests performed in community laboratories in Ontario between October 2008 and September 2009 (provided by the Ontario Association of Medical Laboratories).
Different threshold levels were used in the studies, thus we reported the percentage of subjects with serum levels of between 25 and 30 nmol/L and between 37.5 and 50 nmol/L. Some studies stratified the results according to factors affecting vitamin D status and two used multivariate models to investigate the effects of these characteristics (including age, season, BMI, vitamin D intake, skin pigmentation, and season) on serum 25(OH)D levels. It’s unclear, however, if these studies were adequately powered for these subgroup analyses.
Study participants generally consisted of healthy, community-dwelling subjects and most excluded individuals with conditions or medications that alter vitamin D or bone metabolism, such as kidney or liver disease. Although the studies were conducted in different parts of Canada, fewer were performed in Northern latitudes, i.e. above 53°N, which is equivalent to the city of Edmonton.
Adults
Serum vitamin D levels of < 25 to 30 nmol/L were observed in 0% to 25.5% of the subjects included in five studies; the weighted average was 3.8% (95% CI: 3.0, 4.6). The preliminary results of the Canadian survey showed that approximately 5% of the subjects had serum levels below 29.5 nmol/L. The results of over 600,000 vitamin D tests performed in Ontarian community laboratories between October 2008 and September 2009 showed that 2.6% of adults (> 18 years) had serum levels < 25 nmol/L.
The prevalence of serum vitamin D levels below 37.5-50 nmol/L reported among studies varied widely, ranging from 8% to 73.6% with a weighted average of 22.5%. The preliminary results of the CHMS survey showed that between 10% and 25% of subjects had serum levels below 37 to 48 nmol/L. The results of the vitamin D tests performed in community laboratories showed that 10% to 25% of the individuals had serum levels between 39 and 50 nmol/L.
In an attempt to explain this inter-study variation, the study results were stratified according to factors affecting serum vitamin D levels, as summarized below. These results should be interpreted with caution as none were adjusted for other potential confounders. Adequately powered multivariate analyses would be necessary to determine the contribution of risk factors to lower serum 25(OH)D levels.
Seasonal variation
Three adult studies evaluating serum vitamin D levels in different seasons observed a trend towards a higher prevalence of serum levels < 37.5 to 50 nmol/L during the winter and spring months, specifically 21% to 39%, compared to 8% to 14% in the summer. The weighted average was 23.6% over the winter/spring months and 9.6% over summer. The difference between the seasons was not statistically significant in one study and not reported in the other two studies.
Skin Pigmentation
Four studies observed a trend toward a higher prevalence of serum vitamin D levels < 37.5 to 50 nmol/L in subjects with darker skin pigmentation compared to those with lighter skin pigmentation, with weighted averages of 46.8% among adults with darker skin colour and 15.9% among those with fairer skin.
Vitamin D intake and serum levels
Four adult studies evaluated serum vitamin D levels according to vitamin D intake and showed an overall trend toward a lower prevalence of serum levels < 37.5 to 50 nmol/L with higher levels of vitamin D intake. One study observed a dose-response relationship between higher vitamin D intake from supplements, diet (milk), and sun exposure (results not adjusted for other variables). It was observed that subjects taking 50 to 400 IU or > 400 IU of vitamin D per day had a 6% and 3% prevalence of serum vitamin D level < 40 nmol/L, respectively, versus 29% in subjects not on vitamin D supplementation. Similarly, among subjects drinking one or two glasses of milk per day, the prevalence of serum vitamin D levels < 40 nmol/L was found to be 15%, versus 6% in those who drink more than two glasses of milk per day and 21% among those who do not drink milk. On the other hand, one study observed little variation in serum vitamin D levels during winter according to milk intake, with the proportion of subjects exhibiting vitamin D levels of < 40 nmol/L being 21% among those drinking 0-2 glasses per day, 26% among those drinking > 2 glasses, and 20% among non-milk drinkers.
The overall quality of evidence for the studies conducted among adults was deemed to be low, although it was considered moderate for the subgroups of skin pigmentation and seasonal variation.
Newborn, Children and Adolescents
Five Canadian studies evaluated serum vitamin D levels in newborns, children, and adolescents. In four of these, it was found that between 0 and 36% of children exhibited deficiency across age groups with a weighted average of 6.4%. The results of over 28,000 vitamin D tests performed in children 0 to 18 years old in Ontario laboratories (Oct. 2008 to Sept. 2009) showed that 4.4% had serum levels of < 25 nmol/L.
According to two studies, 32% of infants 24 to 30 months old and 35.3% of newborns had serum vitamin D levels of < 50 nmol/L. Two studies of children 2 to 16 years old reported that 24.5% and 34% had serum vitamin D levels below 37.5 to 40 nmol/L. In both studies, older children exhibited a higher prevalence than younger children, with weighted averages 34.4% and 10.3%, respectively. The overall weighted average of the prevalence of serum vitamin D levels < 37.5 to 50 nmol/L among pediatric studies was 25.8%. The preliminary results of the Canadian survey showed that between 10% and 25% of subjects between 6 and 11 years (N= 435) had serum levels below 50 nmol/L, while for those 12 to 19 years, 25% to 50% exhibited serum vitamin D levels below 50 nmol/L.
The effects of season, skin pigmentation, and vitamin D intake were not explored in Canadian pediatric studies. A Canadian surveillance study did, however, report 104 confirmed cases1 (2.9 cases per 100,000 children) of vitamin D-deficient rickets among Canadian children age 1 to 18 between 2002 and 2004, 57 (55%) of which from Ontario. The highest incidence occurred among children living in the North, i.e., the Yukon, Northwest Territories, and Nunavut. In 92 (89%) cases, skin pigmentation was categorized as intermediate to dark, 98 (94%) had been breastfed, and 25 (24%) were offspring of immigrants to Canada. There were no cases of rickets in children receiving ≥ 400 IU VD supplementation/day.
Overall, the quality of evidence of the studies of children was considered very low.
Kidney Disease
Adults
Two studies evaluated serum vitamin D levels in Canadian adults with kidney disease. The first included 128 patients with chronic kidney disease stages 3 to 5, 38% of which had serum vitamin D levels of < 37.5 nmol/L (measured between April and July). This is higher than what was reported in Canadian studies of the general population during the summer months (i.e. between 8% and 14%). In the second, which examined 419 subjects who had received a renal transplantation (mean time since transplantation: 7.2 ± 6.4 years), the prevalence of serum vitamin D levels < 40 nmol/L was 27.3%. The authors concluded that the prevalence observed in the study population was similar to what is expected in the general population.
Children
No studies evaluating serum vitamin D levels in Canadian pediatric patients with kidney disease could be identified, although three such US studies among children with chronic kidney disease stages 1 to 5 were. The mean age varied between 10.7 and 12.5 years in two studies but was not reported in the third. Across all three studies, the prevalence of serum vitamin D levels below the range of 37.5 to 50 nmol/L varied between 21% and 39%, which is not considerably different from what was observed in studies of healthy Canadian children (24% to 35%).
Overall, the quality of evidence in adults and children with kidney disease was considered very low.
Clinical Utility of Vitamin D Testing
A high quality comprehensive systematic review published in August 2007 evaluated the association between serum vitamin D levels and different bone health outcomes in different age groups. A total of 72 studies were included. The authors observed that there was a trend towards improvement in some bone health outcomes with higher serum vitamin D levels. Nevertheless, precise thresholds for improved bone health outcomes could not be defined across age groups. Further, no new studies on the association were identified during an updated systematic review on vitamin D published in July 2009.
With regards to non-bone health outcomes, there is no high or even moderate quality evidence that supports the effectiveness of vitamin D in outcomes such as cancer, cardiovascular outcomes, and all-cause mortality. Even if there is any residual uncertainty, there is no evidence that testing vitamin D levels encourages adherence to Health Canada’s guidelines for vitamin D intake. A normal serum vitamin D threshold required to prevent non-bone health related conditions cannot be resolved until a causal effect or correlation has been demonstrated between vitamin D levels and these conditions. This is as an ongoing research issue around which there is currently too much uncertainty to base any conclusions that would support routine vitamin D testing.
For patients with chronic kidney disease (CKD), there is again no high or moderate quality evidence supporting improved outcomes through the use of calcitriol or vitamin D analogs. In the absence of such data, the authors of the guidelines for CKD patients consider it best practice to maintain serum calcium and phosphate at normal levels, while supplementation with active vitamin D should be considered if serum PTH levels are elevated. As previously stated, the authors of guidelines for CKD patients believe that there is not enough evidence to support routine vitamin D [25(OH)D] testing. According to what is stated in the guidelines, decisions regarding the commencement or discontinuation of treatment with calcitriol or vitamin D analogs should be based on serum PTH, calcium, and phosphate levels.
Limitations associated with the evidence of vitamin D testing include ambiguities in the definition of an ‘adequate threshold level’ and both inter- and intra- assay variability. The MAS considers both the lack of a consensus on the target serum vitamin D levels and assay limitations directly affect and undermine the clinical utility of testing. The evidence supporting the clinical utility of vitamin D testing is thus considered to be of very low quality.
Daily vitamin D intake, either through diet or supplementation, should follow Health Canada’s recommendations for healthy individuals of different age groups. For those with medical conditions such as renal disease, liver disease, and malabsorption syndromes, and for those taking medications that may affect vitamin D absorption/metabolism, physician guidance should be followed with respect to both vitamin D testing and supplementation.
Conclusions
Studies indicate that vitamin D, alone or in combination with calcium, may decrease the risk of fractures and falls among older adults.
There is no high or moderate quality evidence to support the effectiveness of vitamin D in other outcomes such as cancer, cardiovascular outcomes, and all-cause mortality.
Studies suggest that the prevalence of vitamin D deficiency in Canadian adults and children is relatively low (approximately 5%), and between 10% and 25% have serum levels below 40 to 50 nmol/L (based on very low to low grade evidence).
Given the limitations associated with serum vitamin D measurement, ambiguities in the definition of a ‘target serum level’, and the availability of clear guidelines on vitamin D supplementation from Health Canada, vitamin D testing is not warranted for the average risk population.
Health Canada has issued recommendations regarding the adequate daily intake of vitamin D, but current studies suggest that the mean dietary intake is below these recommendations. Accordingly, Health Canada’s guidelines and recommendations should be promoted.
Based on a moderate level of evidence, individuals with darker skin pigmentation appear to have a higher risk of low serum vitamin D levels than those with lighter skin pigmentation and therefore may need to be specially targeted with respect to optimum vitamin D intake. The cause-effect of this association is currently unclear.
Individuals with medical conditions such as renal and liver disease, osteoporosis, and malabsorption syndromes, as well as those taking medications that may affect vitamin D absorption/metabolism, should follow their physician’s guidance concerning both vitamin D testing and supplementation.
PMCID: PMC3377517  PMID: 23074397
24.  Current Clinical Practice Scenario of Osteoporosis Management in India 
Background
Various osteoporosis guidelines are available for practice.
Aim
To understand the current clinical practice scenario from the perspective of Indian orthopaedicians, especially about the epidemiology, clinical manifestations, approach to diagnosis and management and patient compliance patterns to long term treatment.
Materials and Methods
A pre-validated structured questionnaire containing questions (mostly objective, some open-ended) catering to various objectives of the study was circulated amongst orthopaedic surgeons across India by means of post/courier, after giving a brief overview of the study telephonically. Data was extracted from the completed questionnaires, and analysed using Microsoft Excel software.
Results
The questionnaire was filled by a total of 84 orthopaedicians throughout India. The prevalence of osteoporosis in India according to the orthopaedic surgeons was 38.4% and there was a female preponderance. Most of the respondents felt out of every 100 osteoporosis patients in India, less than 20 patients are actually diagnosed and treated for osteoporosis. The most common initial presenting feature of established osteoporosis cases was general symptoms. Most respondents preferred Dual-energy X-ray absorptiometry (DEXA) as the initial investigation for the diagnosis of osteoporosis in a patient presenting with typical features. While most respondents preferred once-a-month oral over intravenous (IV) bisphosphonates, they agreed that IV administration had advantages such as lower gastrointestinal side effects and improved compliance. The average duration of therapy of oral bisphosphonates was the longest (27.04 months) among the other anti- osteoporosis therapies that they used. On an average, the patient compliance rate in osteoporosis management was around 64%. IV Zoledronic acid (ZA) and intranasal calcitonin were infrequently used than other anti- osteoporosis therapies. While concerns about cost and availability deterred more frequent usage, there was an agreement that if used regularly these two agents may improve compliance rates among patients.
Conclusion
Current clinical practice scenario of osteoporosis management in India largely adheres to various clinical practice guidelines for osteoporosis. Side effects and lengthy duration of therapy with bisphosphonates seem to be the main factors leading to a low patient compliance. Widespread popularization of once-yearly Zoledronic acid and intranasal calcitonin spray may improve patient compliance and reduce side effect incidence.
doi:10.7860/JCDR/2015/13000.6635
PMCID: PMC4625298  PMID: 26557579
Bisphosphonates; Calcitonin; Compliance; Osteoporosis; Zoledronate
25.  Orthopedic Surgeon's Awareness Can Improve Osteoporosis Treatment Following Hip Fracture: A Prospective Cohort Study 
Journal of Korean Medical Science  2011;26(11):1501-1507.
Through retrospective Jeju-cohort study at 2005, we found low rates of detection of osteoporosis (20.1%) and medication for osteoporosis (15.5%) in those who experienced hip fracture. This study was to determine the orthopedic surgeons' awareness could increase the osteoporosis treatment rate after a hip fracture and the patient barriers to osteoporosis management. We prospectively followed 208 patients older than 50 yr who were enrolled for hip fractures during 2007 in Jeju-cohort. Thirty four fractures in men and 174 in women were treated at the eight hospitals. During the study period, orthopedic surgeons who worked at these hospitals attended two education sessions and were provided with posters and brochures. Patients were interviewed 6 months after discharge using an evaluation questionnaire regarding their perceptions of barriers to osteoporosis treatment. The patients were followed for a minimum of one year. Ninety-four patients (45.2%) underwent detection of osteoporosis by dual energy x-ray absorptiometry and 67 (32.2%) were prescribed medication for osteoporosis at the time of discharge. According to the questionnaire, the most common barrier to treatment for osteoporosis after a hip fracture was patients reluctance. The detection and medication rate for osteoporosis after hip fracture increased twofold after orthopedic surgeons had attended the intervention program. Nevertheless, the osteoporosis treatment rate remains inadequate.
doi:10.3346/jkms.2011.26.11.1501
PMCID: PMC3207055  PMID: 22065908
Hip Fractures; Orthopedic Surgeon; Osteoporosis; Treatment

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