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1.  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
2.  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
3.  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
4.  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
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.  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
7.  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
8.  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
9.  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
10.  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
11.  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
12.  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
13.  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
14.  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
15.  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
16.  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
17.  The Detection of Patients with ‘Fragility Fractures’ in Fracture Clinic – An Audit of Practice with Reference to Recent British Orthopaedic Association Guidelines 
INTRODUCTION
The British Orthopaedic Association published guidelines on the care of fragility fracture patients in 2003. A section of these guidelines relates to the secondary prevention of osteoporotic fractures. The objective of this audit was to compare practice in our fracture clinic to these guidelines, and take steps to improve our practice if required.
PATIENTS AND METHODS
We retrospectively audited the treatment of all 462 new patients seen in January and February 2004. Using case note analysis, 38 patients who had sustained probable fragility fractures were selected. Six months' post-injury, a telephone questionnaire was administered to confirm the nature of the injury and to find out whether the patient had been assessed, investigated or treated for osteoporosis. A second similar audit was conducted a year later after steps had been taken to improve awareness amongst the orthopaedic staff and prompt referral.
RESULTS
During the first audit period, only 5 of 38 patients who should have been assessed and investigated for osteoporosis were either referred or offered referral. This improved to 23 out of 43 patients during the second audit period.
CONCLUSIONS
Improvements in referral and assessment rates of patients at risk of further fragility fractures can be achieved relatively easily by taking steps to increase awareness amongst orthopaedic surgeons, although additional strategies and perhaps the use of automated referral systems may be required to achieve referral rates nearer 100%.
doi:10.1308/003588407X168217
PMCID: PMC1964562  PMID: 17346409
Fragility fracture; Osteoporosis; DEXA
18.  A cross-sectional study of bone health in multiple sclerosis 
Neurology  2009;73(17):1394-1398.
Background:
Osteoporosis is an important risk factor for fragility fractures. Although osteoporosis is considered common in multiple sclerosis (MS), few previous studies focused on fractures in MS.
Objective:
Using the North American Research Committee on Multiple Sclerosis (NARCOMS) Registry, we investigated the frequency of osteoporosis, fractures, and clinical risk factors for fracture in MS.
Methods:
In 2007, 9,346 NARCOMS participants reported fractures and clinical risk factors for fractures including history of osteoporosis or osteopenia (low bone mass), sedentary level of physical activity, falls in the last year, current smoking status, family history of osteoporosis, and impaired mobility.
Results:
Among responders, 2,501 (27.2%) reported low bone mass. More than 15% of responders reported a history of fracture after age 13 years (n = 1,482). Among those reporting fractures, 685 (46.2%) reported multiple fractures, while 522 (35.2%) reported a wrist fracture, 165 (11.1%) reported a vertebral fracture, and 100 (7.4%) reported a hip fracture. Excluding age, 1,413 (15.1%) participants had 1 clinical risk factor for fracture, 2,341 (25.0%) had 2, and 5,393 (57.7%) had 3 or more. Among participants with a history of fracture, 746 (55%) reported taking calcium supplements, 858 (68.8%) reported taking vitamin D supplements or a multivitamin with vitamin D, and 334 (22.5%) reported taking a bisphosphonate.
Conclusion:
Patients with multiple sclerosis (MS) often have multiple risk factors for osteoporotic fractures. Many patients with MS with low bone mass or previous fractures are not taking supplemental calcium or vitamin D, suggesting a potential area of improvement in care.
GLOSSARY
= multiple sclerosis;
= North American Research Committee on Multiple Sclerosis;
= Patient Determined Disease Steps;
= socioeconomic status.
doi:10.1212/WNL.0b013e3181beece8
PMCID: PMC2769555  PMID: 19858462
19.  Clinical risk factors as predictors of postmenopausal osteoporosis in general practice. 
BACKGROUND: Case-finding strategies to identify women with high risk for osteoporotic fractures have recently been proposed, but little information about such an approach in general practice is known. AIM: To study the validity of the proposed case-finding strategy for osteoporosis. DESIGN OF STUDY: Survey using case-finding strategy. SETTING: Seven hundred and twelve women aged between 55 and 84 years, randomly selected from a general practice in The Netherlands. METHOD: Of the 712 randomly selected women, 449 women participated. Information was obtained from a questionnaire, direct questioning, and computerised patients files. Bone mineral density of the femoral neck was measured by dual energy X-ray absorptiometry and vertebral morphometry was performed on lateral X-rays of the spine. Osteoporosis was defined by a bone mineral density T-score of less than 2.5 and/or the presence of severe vertebral deformities. Sensitivity, specificity, and predictive values were calculated for the whole set of risk factors; those significantly associated with osteoporosis and in logistic models. RESULTS: Clinical risk factors were present in 55% of the women and identified 68% of the women with osteoporosis. Three risk factors--a low body mass index, fragility fractures, and severe kyphosis and/or loss of height--were associated significantly with osteoporosis; they were present in 33% of the women and identified 60% of those with osteoporosis. A logistic model based on age and fragility fractures selected 32% of the women and identified 76%. CONCLUSION: No single risk factor could assist in identifying women with osteoporosis. A simplified case-finding strategy using only three risk factors, that is suitable for primary care, reduces the number of women to be evaluated by two-thirds; however, this is at the cost of missing the diagnosis in 40% of the women with osteoporosis. Addition of spine radiographs to the case-finding approach helped to obtain a better risk profile of the women and had also practical consequences for the management of some. We propose that radiographs should be included in any case-finding strategy.
PMCID: PMC1314125  PMID: 11677703
20.  Evaluation and Management of Osteoporosis Following Hospitalization for Low-impact Fracture 
OBJECTIVE
To evaluate the pattern of osteoporosis evaluation and management in postmenopausal women who present with low-impact (minimal trauma) fracture.
DESIGN
Retrospective chart review of patients admitted with a fracture in the absence of trauma or bone disease. Telephone follow-up survey was conducted at 12 months after discharge to collect information on physician visits, pharmacological therapies for osteoporosis, functional status, and subsequent fractures.
PATIENTS/PARTICIPANTS
Postmenopausal women admitted to a hospital in St. Paul, Minnesota between June 1996 and December 1997 for low-impact fractures were identified. Low-impact fracture was defined as a fracture occurring spontaneously or from a fall no greater than standing height. Retrospective review of 301 patient medical records was conducted to obtain data on pre-admission risk factors for osteoporosis and/or fracture, and osteoporosis-related evaluation and management during the course of hospitalization. Follow-up 1 year after the incident fracture was obtained on 227 patients.
MEASUREMENTS AND MAIN RESULTS
Two hundred twenty-seven women were included in the study. Osteoporosis was documented in the medical record in 26% (59/227) of the patients at hospital discharge. Within 12 months of hospital discharge, 9.6% (22/227) had a bone mineral density test, and 26.4% (60/227) were prescribed osteoporosis treatment. Of those who were prescribed osteoporosis treatment, 86.6% (52/60) remained on therapy for 1 year. Nineteen women suffered an additional fracture. Compared to women without a prior fracture, women with at least 1 fracture prior to admission were more likely to have osteoporosis diagnosed and to receive osteoporosis-related medications.
CONCLUSION
Despite guidelines that recommend osteoporosis evaluation in adults experiencing a low-trauma fracture, we report that postmenopausal women hospitalized for low-impact fracture were not sufficiently evaluated or treated for osteoporosis during or after their hospital stay. There are substantial opportunities for improvement of care in this high-risk population to prevent subsequent fractures.
doi:10.1046/j.1525-1497.2003.20387.x
PMCID: PMC1494813  PMID: 12534759
low-impact; fracture; osteoporosis; evaluation; osteoporosis treatment
21.  Bone mineral density testing after fragility fracture 
Canadian Family Physician  2013;59(12):e564-e571.
Abstract
Objective
To determine the proportion of patients with fragility fractures who can be expected to have low bone mineral density (BMD) at the time of fracture and to assist FPs in deciding whether to refer patients for BMD testing.
Data sources
MEDLINE, EMBASE, and CINAHL were searched from the earliest available dates through September 2009.
Study selection
English-language articles reporting BMD test results of patients with fragility fractures who were managed in an orthopedic environment (eg, fracture clinic, emergency management by orthopedic surgeons, inpatients) were eligible for review. While the orthopedic environment has been identified as an ideal point for case finding, FPs are often responsible for investigation and treatment. Factors that potentially influenced BMD test results (eg, selection of fracture types, exclusion criteria) were identified. Studies with 2 or more selection factors of potential influence were flagged, and rates of low BMD were calculated including and excluding these studies.
Synthesis
The distribution of the proportion of persons with low BMD was summarized across studies using descriptive statistics. We calculated lower boundaries on this distribution, using standard statistical thresholds, to determine a lower threshold of the expected rate of low BMD.
Conclusion
Family physicians evaluating patients with fragility fractures can expect that at least two-thirds of patients with fragility fractures who are older than 50 years of age will have low BMD (T score ≤ −1.0). With this a priori expectation, FPs might more readily conduct a fracture risk assessment and pursue warranted fracture risk reduction strategies following fragility fracture.
PMCID: PMC3860947  PMID: 24336562
22.  2002 clinical practice guidelines for the diagnosis and management of osteoporosis in Canada 
Objective
To revise and expand the 1996 Osteoporosis Society of Canada clinical practice guidelines for the management of osteoporosis, incorporating recent advances in diagnosis, prevention and management of osteoporosis, and to identify and assess the evidence supporting the recommendations.
Options
All aspects of osteoporosis care and its fracture complications — including classification, diagnosis, management and methods for screening, as well as prevention and reducing fracture risk — were reviewed, revised as required and expressed as a set of recommendations.
Outcomes
Strategies for identifying and evaluating those at high risk; the use of bone mineral density and biochemical markers in diagnosis and assessing response to management; recommendations regarding nutrition and physical activity; and the selection of pharmacologic therapy for the prevention and management of osteoporosis in men and women and for osteoporosis resulting from glucocorticoid treatment.
Evidence
All recommendations were developed using a justifiable and reproducible process involving an explicit method for the evaluation and citation of supporting evidence.
Values
All recommendations were reviewed by members of the Scientific Advisory Council of the Osteoporosis Society of Canada, an expert steering committee and others, including family physicians, dietitians, therapists and representatives of various medical specialties involved in osteoporosis care (geriatric medicine, rheumatology, endocrinology, obstetrics and gynecology, nephrology, radiology) as well as methodologists from across Canada.
Benefits, harm and costs
Earlier diagnosis and prevention of fractures should decrease the medical, social and economic burdens of this disease.
Recommendations
This document outlines detailed recommendations pertaining to all aspects of osteoporosis. Strategies for identifying those at increased risk (i.e., those with at least one major or 2 minor risk factors) and screening with central dual-energy x-ray absorptiometry at age 65 years are recommended. Bisphosphonates and raloxifene are first-line therapies in the prevention and treatment of postmenopausal osteoporosis. Estrogen and progestin/progesterone is a first-line therapy in the prevention and a second-line therapy in the treatment of postmenopausal osteoporosis. Nasal calcitonin is a second-line therapy in the treatment of postmenopausal osteoporosis. Although not yet approved for use in Canada, hPTH(1-34) is expected to be a first-line treatment for postmenopausal women with severe osteoporosis. Ipriflavone, vitamin K and fluoride are not recommended. Bisphosphonates are the first-line therapy for the prevention and treatment of osteoporosis in patients requiring prolonged glucocorticoid therapy and for men with osteoporosis. Nasal or parenteral calcitonin is a first-line treatment for pain associated with acute vertebral fractures. Impact-type exercise and age-appropriate calcium and vitamin D intake are recommended for the prevention of osteoporosis. Validation: All recommendations were graded according to the strength of the evidence; where the evidence was insufficient and recommendations were based on consensus opinion alone, this is indicated. These guidelines are viewed as a work in progress and will be updated periodically in response to advances in this field.
PMCID: PMC134653  PMID: 12427685
23.  A systematic review of the effectiveness of interventions to improve post-fracture investigation and management of patients at risk of osteoporosis 
Background
There is a large quality of care gap for patients with osteoporosis. As a fragility fracture is a strong indicator of underlying osteoporosis, it offers an ideal opportunity to initiate investigation and treatment. However, studies of post-fracture populations document screening and treatment rates below 20% in most settings. This is despite the fact that bone mineral density (BMD) scans are effective at identifying patients at high risk of fracture, and effective drug treatments are widely available. Effective interventions are required to remedy this incongruity in current practice.
Methods
This study reviewed randomised controlled trials (RCT) involving fully qualified healthcare professionals caring for patients with a fragility fracture in all healthcare settings. Any intervention designed to modify the behaviour of healthcare professionals or implement a service delivery change was considered. The main outcomes were BMD scanning and osteoporosis treatment with anti-resorptive therapy. The electronic databases Medline and Embase were searched from 1994 to June 2010 to identify relevant articles in English. Post-intervention risk differences (RDs) were calculated for the main outcomes and any additional study primary outcomes; the trials were meta-analysed.
Results
A total of 2814 potentially relevant articles were sifted; 18 were assessed in full text. Nine RCTs evaluating ten interventions met the inclusion criteria for the review. All were from North America. Four studies focused on patients with a hip fracture, three on fractures of the wrist/distal forearm, and two included several fracture sites consistent with a fragility fracture. All studies reported positive effects of the intervention for the main study outcomes of BMD scanning and osteoporosis treatment. For BMD scanning the overall risk ratio (95% CI) was 2.8 (2.16 to 3.64); the RD was 36% (21% to 50%). For treatment with anti-resorptive therapy the overall risk ratio (95% CI) was 2.48 (1.92 to 3.2); the RD was 20% (10% to 30%).
Conclusions
All interventions produced positive effects on BMD scanning and osteoporosis treatment rates post-fracture. Despite sizeable increases, investigation and treatment rates remain sub-optimal. Long-term compliance with osteoporosis medications needs to be addressed, as the majority of studies reported treatment rates at six-month follow up only. Studies would be more informative if treatment criteria were defined a priori to facilitate understanding of whether patients were being treated appropriately and integrated economic analyses would be helpful for informing policy implementation decisions.
doi:10.1186/1748-5908-5-80
PMCID: PMC2988064  PMID: 20969769
24.  Osteoporosis management in long-term care. Survey of Ontario physicians. 
Canadian Family Physician  2000;46:2228-2235.
OBJECTIVE: To survey physicians in Ontario regarding their approach to diagnosis and treatment of osteoporosis among residents of long-term care facilities. DESIGN: Mailed questionnaire covering physician demographics; current clinical practice relating to osteoporosis; and perceived barriers to prevention, diagnosis, and treatment of the disease. SETTING: Long-term care facilities in Ontario. PARTICIPANTS: Medical directors of long-term care facilities. MAIN OUTCOME MEASURES: Demographic variables; physician attitudes; and practices concerning awareness, diagnosis, and treatment of osteoporosis. RESULTS: Respondents returned 275 of 490 questionnaires, for a response rate of 56.1%. Most respondents (92.4%) were family physicians; 28.7% were caring for more than 100 patients in long-term care. Most (85.8%) saw from one to 10 hip fractures yearly in their practices. Although 49.6% of respondents estimated the prevalence of osteoporosis to be 40% to 80% among their long-term care patients, 45.5% said that they did not routinely assess their patients for the disease, and 26.8% do not routinely treat it. Half (50.9%) of physicians would treat patients at high risk based on clinical history; 47.9% if patients had a vertebral compression fracture on plain x-ray examination; 43.8% if patients were highly functional; 42.0% if osteoporosis were confirmed with bone mineral densitometry; and 30.0% if patients had a recent fracture. Perceived barriers to initiating treatment included cost of therapy, patient or family reluctance to accept therapy, and time or cost of diagnosis. CONCLUSION: Although physicians are aware that patients in long-term care facilities are at high risk for osteoporosis and hip fractures, the disease remains underdiagnosed and undertreated.
PMCID: PMC2145077  PMID: 11143582
25.  Vitamin K Supplementation in Postmenopausal Women with Osteopenia (ECKO Trial): A Randomized Controlled Trial 
PLoS Medicine  2008;5(10):1-12.
Background
Vitamin K has been widely promoted as a supplement for decreasing bone loss in postmenopausal women, but the long-term benefits and potential harms are unknown. This study was conducted to determine whether daily high-dose vitamin K1 supplementation safely reduces bone loss, bone turnover, and fractures.
Methods and Findings
This single-center study was designed as a 2-y randomized, placebo-controlled, double-blind trial, extended for earlier participants for up to an additional 2 y because of interest in long-term safety and fractures. A total of 440 postmenopausal women with osteopenia were randomized to either 5 mg of vitamin K1 or placebo daily. Primary outcomes were changes in BMD at the lumbar spine and total hip at 2 y. Secondary outcomes included changes in BMD at other sites and other time points, bone turnover markers, height, fractures, adverse effects, and health-related quality of life. This study has a power of 90% to detect 3% differences in BMD between the two groups. The women in this study were vitamin D replete, with a mean serum 25-hydroxyvitamin D level of 77 nmol/l at baseline. Over 2 y, BMD decreased by −1.28% and −1.22% (p = 0.84) (difference of −0.06%; 95% confidence interval [CI] −0.67% to 0.54%) at the lumbar spine and −0.69% and −0.88% (p = 0.51) (difference of 0.19%; 95% CI −0.37% to 0.75%) at the total hip in the vitamin K and placebo groups, respectively. There were no significant differences in changes in BMD at any site between the two groups over the 2- to 4-y period. Daily vitamin K1 supplementation increased serum vitamin K1 levels by 10-fold, and decreased the percentage of undercarboxylated osteocalcin and total osteocalcin levels (bone formation marker). However, C-telopeptide levels (bone resorption marker) were not significantly different between the two groups. Fewer women in the vitamin K group had clinical fractures (nine versus 20, p = 0.04) and fewer had cancers (three versus 12, p = 0.02). Vitamin K supplements were well-tolerated over the 4-y period. There were no significant differences in adverse effects or health-related quality of life between the two groups. The study was not powered to examine fractures or cancers, and their numbers were small.
Conclusions
Daily 5 mg of vitamin K1 supplementation for 2 to 4 y does not protect against age-related decline in BMD, but may protect against fractures and cancers in postmenopausal women with osteopenia. More studies are needed to further examine the effect of vitamin K on fractures and cancers.
Trial registration: ClinicalTrials.gov (#NCT00150969) and Current Controlled Trials (#ISRCTN61708241)
Angela Cheung and colleagues investigate whether vitamin K1 can prevent bone loss among postmenopausal women with osteopenia.
Editors' Summary
Background.
Osteoporosis is a bone disease in which the bones gradually become less dense and more likely to break. In the US, 10 million people have osteoporosis and 18 million have osteopenia, a milder condition that precedes osteoporosis. In both conditions, insufficient new bone is made and/or too much old bone is absorbed. Although bone appears solid and unchanging, very little bone in the human body is more than 10 y old. Old bone is continually absorbed and new bone built using calcium, phosphorous, and proteins. Because the sex hormones control calcium and phosphorous deposition in the bones and thus bone strength, the leading cause of osteoporosis in women is reduced estrogen levels after menopause. In men, an age-related decline in testosterone levels can cause osteoporosis. Most people discover they have osteoporosis only when they break a bone, but the condition can be diagnosed and monitored using bone mineral density (BMD) scans. Treatments can slow down or reverse bone loss (antiresorptive therapies) and some (bone formation therapies) can even make bone and build bone tissue.
Why Was This Study Done?
Although regular exercise and a healthy diet can help to keep bones strong, other ways of preventing osteoporosis are badly needed. Recently, the lay media has promoted vitamin K supplements as a way to reduce bone loss in postmenopausal women. Vitamin K (which is found mainly in leafy green vegetables) is required for a chemical modification of proteins called carboxylation. This modification is essential for the activity of three bone-building proteins. In addition, there is some evidence that low bone density and fractures are associated with a low vitamin K intake. However, little is known about the long-term benefits or harms of vitamin K supplements. In this study, the researchers investigate whether a high-dose daily vitamin K supplement can safely reduce bone loss, bone turnover, and fractures in postmenopausal women with osteopenia in a randomized controlled trial called the “Evaluation of the Clinical Use of Vitamin K Supplementation in Post-Menopausal Women With Osteopenia” (ECKO) trial.
What Did the Researchers Do and Find?
In the study, 440 postmenopausal women with osteopenia were randomized to receive 5mg of vitamin K1 (the type of vitamin K in North American food; the recommended daily adult intake of vitamin K1 is about 0.1 mg) or an inactive tablet (placebo) daily for 2 y; 261 of the women continued their treatment for 2 y to gather information about the long-term effects of vitamin K1 supplementation. All the women had regular bone density scans of their lower back and hips and were examined for fractures and for changes in bone turnover. After 2 y and after 4 y, lower back and hip bone density measurements had decreased by similar amounts in both treatment groups. The women who took vitamin K1 had 10-fold higher amounts of vitamin K1 in their blood than the women who took placebo and lower amounts of a bone formation marker; the levels of a bone resorption marker were similar in both groups. Over the 4-y period, fewer women in the vitamin K group had fractures (nine versus 20 women in the placebo group), and fewer had cancer (three versus 12). Finally, vitamin K supplementation was well tolerated over the 4-y period and adverse health effects were similar in the two treatment groups.
What Do These Findings Mean?
These findings indicate that a high daily dose of vitamin K1 provides no protection against the age-related decline in bone density in postmenopausal women with osteopenia, but that vitamin K1 supplementation may protect against fractures and cancers in these women. The apparent contradiction between the effects of vitamin K1 on bone density and on fractures could mean that vitamin K1 supplements strengthen bone by changing factors other than bone density, e.g., by changing its fine structure rather than making it denser. However, because so few study participants had fractures, the difference in the fracture rate between the two treatment groups might have occurred by chance. Larger studies are therefore needed to examine the effect of vitamin K1 on fractures (and on cancer) and, until these are done, high-dose vitamin K1 supplementation should not be recommended for the prevention of osteoporosis.
Additional Information.
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.0050196.
The US National Institute of Arthritis and Musculoskeletal and Skin Diseases provides detailed information about osteoporosis (in English and Spanish) and links to other resources, including an interactive web tool called Check Up On Your Bones
MedlinePlus provides links to additional information about osteoporosis (in English and Spanish)
The MedlinePlus Encyclopedia has a page about vitamin K
The UK Food Standards Agency provides information about vitamin K
Full details about the ECKO trial are available on the ClinicalTrials.gov Web site
The Canadian Task Force for Preventive Health Care provides recommendations on the prevention of osteoporosis and osteoporotic fractures in postmenopausal women
Osteoporosis Canada provides information on current topics related to osteoporosis
doi:10.1371/journal.pmed.0050196
PMCID: PMC2566998  PMID: 18922041

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