Fall-related hip fractures result in significant personal and societal consequences; importantly, up to half of older adults with hip fracture never regain their previous level of mobility. Strategies of follow-up care for older adults after fracture have improved investigation for osteoporosis; but managing bone health alone is not enough. Prevention of fractures requires management of both bone health and falls risk factors (including the contributing role of cognition, balance and continence) to improve outcomes.
This is a parallel group, pragmatic randomized controlled trial to test the effectiveness of a post-fracture clinic compared with usual care on mobility for older adults following their hospitalization for hip fracture. Participants randomized to the intervention will attend a fracture follow-up clinic where a geriatrician and physiotherapist will assess and manage their mobility and other health issues. Depending on needs identified at the clinical assessment, participants may receive individualized and group-based outpatient physiotherapy, and a home exercise program. Our primary objective is to assess the effectiveness of a novel post-discharge fracture management strategy on the mobility of older adults after hip fracture.
We will enrol 130 older adults (65 years+) who have sustained a hip fracture in the previous three months, and were admitted to hospital from home and are expected to be discharged home. We will exclude older adults who prior to the fracture were: unable to walk 10 meters; diagnosed with dementia and/or significant comorbidities that would preclude their participation in the clinical service.
Eligible participants will be randomly assigned to the Intervention or Usual Care groups by remote allocation. Treatment allocation will be concealed; investigators, measurement team and primary data analysts will be blinded to group allocation. Our primary outcome is mobility, operationalized as the Short Physical Performance Battery at 12 months. Secondary outcomes include frailty, rehospitalizations, falls risk factors, quality of life, as well as physical activity and sedentary behaviour. We will conduct an economic evaluation to determine health related costs in the first year, and a process evaluation to ascertain the acceptance of the program by older adults, as well as clinicians and staff within the clinic.
Trial registration number
The objectives are to describe for the first time a home-based exercise intervention for frail elderly hip fracture patients and to describe the feasibility of this exercise program.
A home-based exercise program was used in a randomized controlled trial in which the authors investigated exercise intervention versus no exercise intervention in patients after hip fracture.
This program was implemented at the patients’ own home or place of residence after discharge.
Women 65 years of age or older were recruited within 15 days of hip fracture. Eligible patients were those with a nonpathologic fracture who were admitted within 72 hours of injury, had surgical repair of the hip fracture, and met medical inclusion criteria. Participants initially were randomized to exercise groups and then assigned to exercise trainers.
The exercise contained strength training and aerobic components. Participants were expected to exercise 5 days per week by performing a combination of supervised and independently performed exercise sessions. Intensity and duration were increased gradually by trainers in a standardized way. The frequency of the supervised sessions decreased as participants became more independent. Treatment fidelity visits ensured that the intervention was being delivered as intended across trainers and across participants.
Main Outcome Measurement
This work describes the feasibility and challenges of administering an intensive home-based exercise program in this population of older adults.
Of those patients randomized to exercise, 82% were followed by a trainer and almost all advanced to higher levels in both aerobic and strength programs. Overall, participants received an average of 44 (78.5%) of the prescribed visits by the trainer.
This study showed that it was possible to engage a frail older population of post-hip fracture patients in a program of aerobic and strength training exercise with a high rate of participation.
Background and purpose
The impact of large, randomized trials in orthopedic surgery on surgeons' preferences for a particular surgical approach remains unclear. We surveyed surgeons to assess whether they would change practice based upon results of a large, multicenter randomized controlled hip fracture trial.
We conducted a cross-sectional survey among International Hip Fracture Research Collaborative (IHFRC) surgeons and surgeons who were members of Arbeitsgemeinschaft fuer Osteosynthesefragen - Association for the Study of Internal Fixation (AO/ASIF) to determine the likelihood that they would change practice based on findings of a proposed large, multicenter randomized controlled trial (the Hip Fracture Evaluation with Alternatives of Total Hip Arthroplasty versus Hemi-Arthroplasty (HEALTH) study). We asked surgeons their current preferences for the management of displaced femoral neck fractures and whether a trial that definitively revealed a substantial improvement in function and quality of life with no difference in risk of revision surgery was important and would cause them to change practice.
Of 883 surgeons surveyed, 210 responded from IHFRC and 586 from AO/ASIF (a response rate of 90%). Most surgeons (61%) preferred hemiarthroplasty (HA) for treating displaced femoral neck fractures. 72% of responding surgeons believed that a substantial improvement in patient function with total hip arthroplasty (THA) and no adverse effects on revision surgery would be an important finding. Moreover, of 483 surgeons who preferred hemiarthroplasty, 62% would change their practice based upon the findings of the trial.
Large clinical trials in orthopedics are worthwhile endeavors, as they have the potential to change practice among surgeons. Surgeons seem willing to adopt alternative surgical approaches if the evidence is compelling and sound.
Hip fractures in older people are associated with high morbidity, mortality, disability and reduction in quality of life. Traditionally people with hip fracture are cared for in orthopaedic departments without additional geriatric assessment. However, studies of postoperative rehabilitation indicate improved efficiency of multidisciplinary geriatric rehabilitation as compared to traditional care. This randomized controlled trial (RCT) aims to investigate whether an additional comprehensive geriatric assessment of hip fracture patients in a special orthogeriatric unit during the acute in-hospital phase may improve outcomes as compared to treatment as usual in an orthopaedic unit.
The intervention of interest, a comprehensive geriatric assessment is compared with traditional care in an orthopaedic ward. The study includes 401 home-dwelling older persons >70 years of age, previously able to walk 10 meters and now treated for hip fracture at St. Olav Hospital, Trondheim, Norway. The participants are enrolled and randomised during the stay in the Emergency Department. Primary outcome measure is mobility measured by the Short Physical Performance Battery (SPPB) at 4 months after surgery. Secondary outcomes measured at 1, 4 and 12 months postoperatively are place of residence, activities of daily living, balance and gait, falls and fear of falling, quality of life and depressive symptoms, as well as use of health care resources and survival.
We believe that the design of the study, the randomisation procedure and outcome measurements will be of sufficient strength and quality to evaluate the impact of comprehensive geriatric assessment on mobility and other relevant outcomes in hip fracture patients.
There is limited evidence to support the efficacy of current pharmaceutical agents in reducing the risk of hip fracture in older postmenopausal women with established osteoporosis.
To clarify the efficacy of risedronate in reducing the risk of hip fracture in elderly postmenopausal women aged ≥ 70 years with established osteoporosis, i.e., those with bone mineral density-defined osteoporosis and a prevalent vertebral fracture.
Post hoc analysis of the Hip Intervention Program (HIP) study, a randomized controlled trial comparing risedronate with placebo for reducing the risk of hip fracture in elderly women. Women aged 70 to 100 years with established osteoporosis (baseline femoral neck T-score ≤ −2.5 and ≥1 prior vertebral fracture) were included. The main outcome measure was 3-year hip fracture incidence in the risedronate and placebo groups.
A total of 1656 women met the inclusion criteria. After 3 years, hip fracture had occurred in 3.8% of risedronate-treated patients and 7.4% of placebo-treated patients (relative risk 0.54; 95% confidence interval 0.32–0.91; P = 0.019).
Risedronate significantly reduced the risk of hip fracture in women aged up to 100 years with established osteoporosis.
osteoporosis; postmenopausal; hip fracture; risedronate
Hip fracture patients often have an impaired nutritional status at the time of fracture, which can result in a higher complication rate, prolonged rehabilitation time and increased mortality. A study was designed to evaluate the effect of nutritional intervention on nutritional status, functional status, total length of stay, postoperative complications and cost-effectiveness.
Open-labelled, multi-centre, randomized controlled trial in hip fracture patients aged 55 years and above. The intervention group receives dietetic counselling (by regular home visits and telephone calls) and oral nutritional supplementation for three months after surgery. The control group receives usual dietetic care as provided by the hospital. Outcome assessment is performed at three and six months after hip fracture.
Patient recruitment has started in July 2007 and has ended in December 2009. First results are expected in 2011.
We conducted a randomized controlled trial to assess the efficacy and safety of a multiple-component intervention designed to improve functional recovery after hip fracture. One hundred seventy-six patients who underwent surgery for a primary unilateral hip fracture were assigned randomly to receive usual care (control arm, n = 86) or a brief motivational videotape, supportive peer counseling, and high-intensity muscle-strength training (intervention arm, n = 90). Between-group differences on the physical functioning, role-physical, and social functioning domains of the SF-36 were assessed postoperatively at 6 months. At the end of the trial, 32 intervention and 27 control patients (34%) completed the 6-month outcome assessment. Although patient compliance with all three components of the intervention was uneven, over 90% of intervention patients were exposed to the motivational videotape. Intervention patients experienced a significant (P = 0.03) improvement in the role-physical domain (mean change, −11 ± 33) compared to control patients (mean change, −37 ± 41). Change in general health (P = 0.2) and mental health (P = 0.1) domain scores was also directionally consistent with the study hypothesis. Although our findings are consistent with previous reports of comprehensive rehabilitation efforts for hip fracture patients, the trial was undermined by high attrition and the possibility of self-selection bias at 6-month follow-up. We discuss the methodological challenges and lessons learned in conducting a randomized controlled trial that sought to implement and assess the impact of a complex intervention in a population that proved difficult to follow up once they had returned to the community.
functional recovery; hip fracture; methodology; psychosocial intervention; randomized controlled trial; rehabilitation
Vitamin D is important for gastrointestinal absorption of calcium and phosphorus, for bone mineralization, and is one useful therapeutic component in the prevention and treatment of osteoporosis and osteoporotic fractures. Low levels of 25 hydroxyvitamin D have been implicated as a risk factor for falls, for all fractures in general and for hip fractures in particular. At present there is a gap in the diagnosis and treatment of vitamin D deficiency in older adults with hip fractures.
To explore the distribution of and correlates to levels of vitamin D in a population of patients with a recent hip fracture.
25 hydroxyvitamin D levels were measured in 526 screened subjects and 385 ultimately randomized patients who were part of the HORIZON RFT multinational trial, a randomized, placebo-controlled, double-blind trial testing the efficacy of a yearly intravenous bisphosphonate, zoledronic acid, in the prevention of new clinical fractures in patients with recent hip fracture repair.
In screened patients, levels of 25 hydroxyvitamin D were low (median=14.7 ng/mL, IQR=7.80,22.5,), and 51% were at or below the clinically meaningful threshold of 15 ng/mL. In randomized patients, in bivariate analyses, level of 25 hydroxyvitamin D was significantly (p<0.05) related to male gender (r=0.12), calcium (r=0.16), and bone mineral density at the femoral neck (r=0.22). Low serum 25 hydroxyvitamin D (<15ng/mL) was related only to low calcium (odds=0.15 95%CI= 0.03, 0.63) in multivariate logistic models controlling for gender, age, race, BMI, living at home, alkaline phosphatase, and creatinine clearance. However, low serum calcium is an insensitive and poorly specific means of identifying patients with vitamin D deficiency, with an area under the ROC of 0.6.
We conclude that vitamin D insufficiency is a common problem in this population of subjects who have recently suffered a hip fracture. This insufficiency is related only to calcium in multivariable controlled models, but cannot be reliably identified or excluded by measuring serum calcium alone. Physicians should be encouraged to check and monitor serum levels of 25 hydroxyvitamin D, or to universally treat for vitamin D deficiency in patients experiencing a low trauma hip fracture.
In the absence of head-to-head trials, indirect comparisons of randomized placebo-controlled trials may provide a viable option to assess relative efficacy. The purpose was to estimate the relative efficacy of reduction of fractures in post-menopausal women, and to assess robustness of the results.
A systematic literature review of multiple databases identified randomized placebo-controlled trials with nine drugs for post-menopausal women. Odds ratio and 95% credibility intervals for the rates of hip, non-vertebral, vertebral, and wrist fractures for each drug and between drugs were derived using a Bayesian approach. A drug was ranked as the most efficacious if it had the highest posterior odds ratio, or had the highest effect size.
30 studies including 59,209 patients reported fracture rates for nine drugs: alendronate (6 studies), denosumab (1 study), etidronate (8 studies), ibandronate (4 studies), raloxifene (1 study), risedronate (7 studies), strontium (2 study), teriparatide (1 study), and zoledronic acid (1 study). The drugs with the highest probability of reducing non-vertebral fractures was etidronate and teriparatide while the drugs with the highest probability of reducing vertebral, hip or wrist fractures were teriparatide, zoledronic acid and denosumab. The drugs with the largest effect size for vertebral fractures were zoledronic acid, teriparatide and denosumab, while the drugs with the highest effect size for non-vertebral, hip or wrist fractures were alendronate or risedronate. Estimates were consistent between Bayesian and classical approaches.
Teriparatide, zoledronic acid and denosumab have the highest probabilities of being most efficacious for non-vertebral and vertebral fractures, and having the greatest effect sizes. The estimates from indirect comparisons were robust to differences in methodology.
Osteoporosis most commonly affects postmenopausal women, placing them at a significant risk of fractures. In particular, hip fractures are an important cause of mortality and morbidity among postmenopausal women. Anti-resorptive therapies that produce greater decreases in bone turnover markers together with greater increases in bone mineral density (BMD) are associated with greater reductions in fracture risk, especially at sites primarily composed of cortical bone such as the hip. Thus, treatment with potent anti-resorptive drugs like alendronate is a strategy for preventing hip fractures in postmenopausal women with osteoporosis. The purpose of this paper is to discuss the efficacy of alendronate against hip fractures and the mechanism for this anti-fracture efficacy in postmenopausal women with osteoporosis. A meta-analysis of randomized controlled trials has shown that alendronate reduces the risk of hip fractures by 55% in postmenopausal women with osteoporosis. According to the analyses of the Fracture Intervention Trial, each 1 standard deviation reduction in a 1-year change in bone-specific alkaline phosphatase (BSAP) is associated with 39% fewer hip fractures in alendronate-treated postmenopausal women, and those with at least 30% reduction in BSAP have a 74% lower risk of hip fractures relative to those with less than 30%. Alendronate is effective in reducing the risk of hip fractures across a spectrum of ages. The mechanism for this anti-fracture efficacy has been clarified; alendronate strongly suppresses bone turnover and subsequently increases hip BMD, decreases cortical porosity, improves parameters of hip structure geometry (cortical thickness, cross-sectional area, section modulus, and buckling ratio), and produces more uniform mineralization (increases the mean degree of mineralization of bone) in cortical bone. A once-weekly regimen of alendronate administration provides better patient compliance and persistence with the treatment than the once-daily dosing regimen, leading to greater efficacy against hip fractures. Thus, the efficacy of alendronate against hip fractures has been confirmed in postmenopausal women with osteoporosis, especially with a once-weekly dosing regimen.
hip fracture; bone turnover; bone mineral density; cortical porosity; cortical thickness
Purpose: Best rehabilitation practices after hip fracture for people with dementia have not been established. A systematic review was conducted to determine current evidence for rehabilitation in this population, including residents in continuing care. Methods: Standardized review methodology was used to search eight databases for literature on hip-fracture rehabilitation for people with dementia. Eligible studies included participants with dementia who had a hip fracture; performed a rehabilitation intervention; and evaluated one or more of function, ambulation, discharge location, or falls. The Newcastle–Ottawa Scale was used to assess validity. Results: A total of 13 studies were included: five randomized controlled trials (RCTs), seven prospective cohort series, and one retrospective cohort study. Average quality ratings for RCTs and cohort studies were good and fair respectively. Participants with mild to moderate dementia receiving rehabilitation showed similar relative gains in function to those without dementia. Only one study examined the effect of rehabilitation among residents in continuing care. Conclusions: People with mild or moderate dementia may show improved function and ambulation and decreased fall risk after rehabilitation post hip fracture, similar to gains achieved by those without dementia. More research is required to ascertain the effect of rehabilitation in people with moderate to severe dementia, including those residing in continuing-care settings.
dementia; geriatrics; hip fractures; rehabilitation; démence; fracture de la hanche; maladie d'Alzheimer; patients gériatriques; réadaptation
To evaluate the association between the long-term use of bisphosphonates and the risk of hip fracture compared to never use among women aged 65 years or older.
Case–control study nested in a cohort.
General practice research database operated by the Spanish Medicines Agency.
Cases of hip fracture were defined as women aged 65 years or older with a validated first diagnosis of hip fracture between 2005 and 2008. Five controls free of hip fracture were matched on age and calendar-year with each case.
Information on bisphosphonate use, hip fractures, comedication and comorbidities was collected.
Hip fracture risk comparing bisphosphonate users versus never users.
Hip fracture risk comparing bisphosphonate users versus never users by individual drugs.
The study included 2009 incident hip fractures and 10 045 matched controls. Hip-fracture risk did not differ between bisphosphonate users and never users, adjusted OR=1.09 (95% CI 0.94 to 1.27). No association was observed between hip fracture risk and cumulative duration of bisphosphonate treatment. However, when treatment duration is analysed as time since first prescription, hip fracture risks of the different subgroups compared to never users obtained were as follows: <1 year, OR 0.85 (95% CI 0.60 to 1.21); 1 to <3 years, OR 1.02 (95% CI 0.82 to 1.26); ≥3 years, OR 1.32 (95% CI 1.05 to 1.65) (p for trend=0.03).
Ever use of oral bisphosphonates was not associated with a decreased risk of hip fracture in women aged 65 or older as compared to never use. No association was observed between hip fracture risk and cumulative duration of bisphosphonate treatment. However, when treatment duration is analysed as time since first prescription, a statistically significant increased risk for hip fracture was observed in patients exposed to bisphosphonates over 3 years.
Spanish Ministry of Health. TRA-071
CLINICAL PHARMACOLOGY; EPIDEMIOLOGY; PRIMARY CARE
To cope at their homes, community-dwelling older people surviving a hip fracture need a sufficient amount of functional ability and mobility. There is a lack of evidence on the best practices supporting recovery after hip fracture. The purpose of this article is to describe the design, intervention and demographic baseline results of a study investigating the effects of a rehabilitation program aiming to restore mobility and functional capacity among community-dwelling participants after hip fracture.
Population-based sample of over 60-year-old community-dwelling men and women operated for hip fracture (n = 81, mean age 79 years, 78% were women) participated in this study and were randomly allocated into control (Standard Care) and ProMo intervention groups on average 10 weeks post fracture and 6 weeks after discharged to home. Standard Care included written home exercise program with 5-7 exercises for lower limbs. Of all participants, 12 got a referral to physiotherapy. After discharged to home, only 50% adhered to Standard Care. None of the participants were followed-up for Standard Care or mobility recovery. ProMo-intervention included Standard Care and a year-long program including evaluation/modification of environmental hazards, guidance for safe walking, pain management, progressive home exercise program and physical activity counseling. Measurements included a comprehensive battery of laboratory tests and self-report on mobility limitation, disability, physical functional capacity and health as well as assessments for the key prerequisites for mobility, disability and functional capacity. All assessments were performed blinded at the research laboratory. No significant differences were observed between intervention and control groups in any of the demographic variables.
Ten weeks post hip fracture only half of the participants were compliant to Standard Care. No follow-up for Standard Care or mobility recovery occurred. There is a need for rehabilitation and follow-up for mobility recovery after hip fracture. However, the effectiveness of the ProMo program can only be assessed at the end of the study.
Current Controlled Trials ISRCTN53680197
Hip fractures are among the most common debilitating injuries in the elderly and are a significant cause of morbidity and mortality worldwide. Despite the ever-increasing literature on the topic of hip fractures, optimal treatment remains uncertain. Trials with small sizes, methodological limitations, strict inclusion criteria and wide confidence intervals leave the optimal approach to treating hip fractures unknown and controversial. In 2005, the International Hip Fracture Research Collaborative was officially established with the mandate of resolving controversies in hip fracture management. Presently, two multicenter randomized trials, FAITH and HEALTH, are underway. The FAITH trial (Fixation Using Alternative Implants for the Treatment of Hip Fractures) will compare Sliding Hip Screws and Cancellous Screws; the HEALTH trial (Hip Fracture Evaluation with Alternatives of Total Hip Arthroplasty versus Hemi-Arthroplasty) will compare total hip arthroplasty and hemi-arthroplasty. The present paper reviews current controversies in hip fracture care. Ultimately, only large randomized trials, such as FAITH and HEALTH, will resolve the longstanding controversy of whether primary replacement or fixation is the preferred treatment modality in this common fracture. Subsequent trials need to focus on surgical strategies in the cognitively impaired patient.
Arthroplasty; controversies in fixation; hip fractures
Hip fractures are a significant cause of morbidity and mortality worldwide and the burden of disability associated with hip fractures globally vindicates the need for high-quality research to advance the care of patients with hip fractures. Historically, large, multi-centre randomized controlled trials have been rare in the orthopaedic trauma literature. Similar to other medical specialties, orthopaedic research is currently undergoing a paradigm shift from single centre initiatives to larger collaborative groups. This is evident with the establishment of several collaborative groups in Canada, in the United States, and in Europe, which has proven that multi-centre trials can be extremely successful in orthopaedic trauma research.
Despite ever increasing literature on the topic of his fractures, the optimal treatment of hip fractures remains unknown and controversial. To resolve this controversy large multi-national collaborative randomized controlled trials are required. In 2005, the International Hip Fracture Research Collaborative was officially established following funding from the Canadian Institute of Health Research International Oppurtunity Program with the mandate of resolving controversies in hip fracture management. This manuscript will describe the need, the information, the organization, and the accomplishments to date of the International Hip Fracture Research Collaborative.
PMID: 19550238 CAMSID: cams321
hip fracture; multicenter collaboratives
Hip fracture patients can benefit from nutritional supplementation during their recovery. Up to now, cost-effectiveness evaluation of nutritional intervention in these patients has not been performed. Costs of nutritional intervention are relatively low as compared with medical costs. Cost-effectiveness evaluation shows that nutritional intervention is likely to be cost-effective.
Previous research on the effect of nutritional intervention on clinical outcome in hip fracture patients yielded contradictory results. Cost-effectiveness of nutritional intervention in these patients remains unknown. The aim of this study was to evaluate cost-effectiveness of nutritional intervention in elderly subjects after hip fracture from a societal perspective.
Open-label, multi-centre randomized controlled trial investigating cost-effectiveness of intensive nutritional intervention comprising regular dietetic counseling and oral nutritional supplementation for 3 months postoperatively. Patients allocated to the control group received care as usual. Costs, weight and quality of life were measured at baseline and at 3 and 6 months postoperatively. Incremental cost-effectiveness ratios (ICERs) were calculated for weight at 3 months and quality adjusted life years (QALYs) at 6 months postoperatively.
Of 152 patients enrolled, 73 were randomized to the intervention group and 79 to the control group. Mean costs of the nutritional intervention was 613 Euro. Total costs and subcategories of costs were not significantly different between both groups. Based on bootstrapping of ICERs, the nutritional intervention was likely to be cost-effective for weight as outcome over the 3-month intervention period, regardless of nutritional status at baseline. With QALYs as outcome, the probability for the nutritional intervention being cost-effective was relatively low, except in subjects aged below 75 years.
Intensive nutritional intervention in elderly hip fracture patients is likely to be cost-effective for weight but not for QALYs. Future cost-effectiveness studies should incorporate outcome measures appropriate for elderly patients, such as functional limitations and other relevant outcome parameters for elderly.
Cost-effectiveness; Elderly; Hip fracture; Nutritional support; Quality of life
Hip fracture affects more than 1.6 million persons worldwide and causes substantial changes in body composition, function, and strength. Usual care (UC) has not successfully restored function to most patients, and prior research has not identified an effective restorative program. Our objective was to determine whether a yearlong home-based exercise program initiated following UC could be administered to older patients with hip fracture and improve outcomes.
A randomized controlled trial of 180 community dwelling female patients with hip fracture, 65 years and older, randomly assigned to intervention (n=91) or UC (n=89). Patients were recruited within 15 days of fracture from 3 Baltimore-area hospitals from November 1998 through September 2004. Follow-up assessments were conducted at 2, 6, and 12 months after fracture. The Exercise Plus Program was administered by exercise trainers that included supervised and independently performed aerobic and resistive exercises with increasing intensity. Main outcome measures included bone mineral density of the contralateral femoral neck. Other outcomes included time spent and kilocalories expended in physical activity using the Yale Physical Activity Scale, muscle mass and strength, fat mass, activities of daily living, and physical and psychosocial functioning. The effect of intervention for each outcome was estimated by the difference in outcome trajectories 2 to 12 months after fracture.
More than 80% of participants received trainer visits, with the majority receiving more than 3 quarters (79%) of protocol visits. The intervention group reported more time spent in exercise activity during follow-up (P<.05). Overall, small effect sizes of 0 to 0.2 standard deviations were seen for bone mineral density measures, and no significant patterns of time-specific between-group differences were observed for the remaining outcome measures.
Patients with hip fracture who participate in a yearlong, in-home exercise program will increase activity level compared with those in UC; however, no significant changes in other targeted outcomes were detected.
Medication compliance may be a surrogate for factors that improve health outcomes such as fractures. Little is known about the size of this potential “healthy adherer” effect. We evaluated the hypothesis that compliance with placebo is associated inversely with bone loss and fractures among women participating in the Fracture Intervention Trial (FIT). Compliance with placebo and alendronate was evaluated using daily medication diaries. Women were defined as having high compliance if they took 80% or more of dispensed study medication. Change in bone mineral density (BMD) was assessed using mixed models comparing women with high versus lower compliance with placebo. Cox proportional-hazards models analyzed the association between placebo compliance and various types of fractures. Among 3169 women randomized to placebo, 82% had high compliance. Compared with women with lower placebo compliance, bone loss at the total hip was lower in compliant placebo-treated women (−0.43%/year versus −0.58%/year, p = .04). Among placebo-treated women, there were 46 hip, 110 wrist, 77 clinical vertebral, and 492 total clinical fractures. Compared with women with lower placebo compliance, women with high placebo compliance had a nonsignificant reduced risk for hip fracture [adjusted hazard ratio (HR) = 0.67, 95% confidence interval (CI) 0.30–1.45]. This trend was not observed for other fractures. Medication compliance may be a proxy for factors that confers benefit on reducing hip fracture (but not other types of fractures) independent of the effect of the medication itself. Nonrandomized studies of interventions designed to maintain or improve bone density and/or hip fracture may need to consider medication compliance as a confounder to better estimate true intervention effects. © 2011 American Society for Bone and Mineral Research.
COMPLIANCE; ADHERENCE; HIP FRACTURE; VERTEBRAL FRACTURE; ALENDRONATE; BISPHOSPHONATE
The effects of intervention programs on health-related quality of life (HRQOL) of patients with hip fracture have not been well studied. We hypothesized that older patients with hip fracture who received our interdisciplinary intervention program would have better HRQOL than those who did not.
A randomized experimental design was used. Older patients with hip fracture (N = 162), 60 to 98 years old, from a medical center in northern Taiwan were randomly assigned to an experimental (n = 80) or control (n = 82) group. HRQOL was measured by the SF-36 Taiwan version at 1, 3, 6, and 12 months after discharge.
The experimental group had significantly better overall outcomes in bodily pain (β = 9.38, p = 0.002), vitality (β = 9.40, p < 0.001), mental health (β = 8.16, p = 0.004), physical function (β = 16.01, p < 0.001), and role physical (β = 22.66, p < 0.001) than the control group at any time point during the first year after discharge. Physical-related health outcomes (physical functioning, role physical, and vitality) had larger treatment effects than emotional/mental- and social functioning-related health outcomes.
This interdisciplinary intervention program may improve health outcomes of elders with hip fracture. Our results may provide a reference for health care providers in countries using similar programs with Chinese/Taiwanese immigrant populations.
To test the hypothesis that the reduction in fractures with hormone therapy (HT) is greater in women with lower estradiol levels.
We conducted a nested case-control study within the Women’s Health Initiative HT Trials. The sample included 231 hip fracture case-control pairs and a random sample of 519 all fracture case-control pairs. Cases and controls were matched for age, ethnicity, randomization date, fracture history and hysterectomy status. Hormones were measured prior to randomization. Incident cases of fracture identified over an average follow-up of 6.53 years.
There was no evidence that the effect of HT on fracture differed by baseline estradiol (E2) or sex hormone binding globulin (SHBG). Across all quartiles of E2 and SHBG, women randomized to HT had about a 50% lower risk of fracture including hip fracture, compared to placebo.
The effect of HT on fracture reduction is independent of estradiol and SHBG levels.
hormone therapy; fracture; sex steroid hormones; Women’s Health Initiative.
Objectives: To investigate the efficacy and effectiveness of hip protectors in frail community living older women.
Design: Randomised controlled trial.
Setting: Aged care health services in New South Wales, Australia.
Patients: 600 women 74 years of age or more (mean age 83 years), who had two or more falls or one fall requiring hospital admission in the previous year, and who lived in their own homes.
Intervention: Use of hip protectors.
Main outcome measures: Adherence with use of hip protectors, falls, incidence of hip fracture, and adverse effects of use of hip protectors.
Results: Adherence was approximately 53% over the duration of the study and hip protectors were worn at the time of 51% of falls in the intervention group. The risk of hip fracture when falling while wearing hip protectors, compared with a fall with no hip protectors in place, was significantly reduced (relative risk (RR) 0.23, 95% confidence interval (CI) 0.08 to 0.67). On an intention to treat analysis, 21 and 22 hip fractures occurred in the intervention and control groups respectively (adjusted RR 0.92, 95% CI 0.51 to 1.68). Three users of hip protectors sustained a hip fracture while wearing properly applied protectors, while 16 hip protector users (5%) developed minor local complications.
Conclusions: Hip protectors prevent hip fractures in community dwelling older women if worn at the time of a fall. The overall effectiveness of hip protectors was not established in this study, because of incomplete adherence with use of the protectors, and limited statistical power.
Around one third to one half of patients with hip fractures require red-cell pack transfusion. The increasing incidence of hip fracture has also raised the need for this scarce resource. Additionally, red-cell pack transfusions are not without complications which may involve excessive morbidity and mortality. This makes it necessary to develop blood-saving strategies. Our objective was to assess safety, efficacy, and cost-effictveness of combined treatment of i.v. ferric carboxymaltose and erythropoietin (EPOFE arm) versus i.v. ferric carboxymaltose (FE arm) versus a placebo (PLACEBO arm) in reducing the percentage of patients who receive blood transfusions, as well as mortality in the perioperative period of hip fracture intervention.
Multicentric, phase III, randomized, controlled, double blinded, parallel groups clinical trial. Patients > 65 years admitted to hospital with a hip fracture will be eligible to participate. Patients will be treated with either a single dosage of i.v. ferric carboxymaltose of 1 g and subcutaneous erythropoietin (40.000 IU), or i.v. ferric carboxymaltose and subcutaneous placebo, or i.v. placebo and subcutaneous placebo. Follow-up will be performed until 60 days after discharge, assessing transfusion needs, morbidity, mortality, safety, costs, and health-related quality of life. Intention to treat, as well as per protocol, and incremental cost-effectiveness analysis will be performed. The number of recruited patients per arm is set at 102, a total of 306 patients.
We think that this trial will contribute to the knowledge about the safety and efficacy of ferric carboxymaltose with/without erythropoietin in preventing red-cell pack transfusions in patients with hip fracture. ClinicalTrials.gov identifier: NCT01154491.
Hip fracture; Transfusion; Blood-saving strategies; Ferric carboxymaltose; Erythropoietin; Red-cell pack; Clinical trial
OBJECTIVE: To determine the relative contribution of decline in bone density to the increase in risk of hip fracture with age in men and women. DESIGN: Incidence data of hip fracture from the general population were combined with the bone density distribution in a sample from the same population and with a risk estimate of low bone density known from literature. SETTING: The Netherlands. SUBJECTS: All people with a hospital admission for a hip fracture in 1993, and bone density measured in a sample of 581.4 men and women aged 55 years and over in a district of Rotterdam. MAIN OUTCOME MEASURE: One year cumulative risk of hip fracture by age, sex, and bone density measured at the femoral neck. RESULTS: A quarter of all hip fractures occurred in men. Men reached the same incidence as women at five years older. Controlled for age, the risk of hip fracture by bone density was similar in men and women. The risk of hip fracture increased 13-fold from age 60 to 80; decrease in bone density associated with age contributed 1.9 (95% confidence interval 1.5 to 2.4) in women and 1.6 (1.3 to 1.8) in men. CONCLUSIONS: The risk of hip fracture by age and bone density is similar in men and women. The decrease in bone density associated with age makes a limited contribution to the exponential increase of the risk of hip fracture with age.
Hypovitaminosis D and K due to malnutrition or sunlight deprivation, increased bone resorption due to immobilization, low bone mineral density (BMD) and an increased risk of falls may contribute to an increased risk of hip fractures in patients with Parkinson’s disease. The purpose of the present study was to clarify the efficacy of interventions intended to prevent hip fractures in elderly patients with Parkinson’s disease. PubMed was used to search the literature for randomized controlled trials (RCTs) regarding Parkinson’s disease and hip fractures. The inclusion criteria were 50 or more subjects per group and a study period of 1 year or longer. Five RCTs were identified and the relative risk and 95% confidence interval were calculated for individual RCTs. Sunlight exposure increased serum hydroxyvitamin D [25(OH)D] concentration, improved motor function, decreased bone resorption and increased BMD. Alendronate or risedronate with vitamin D supplementation increased serum 25(OH)D concentration, strongly decreased bone resorption and increased BMD. Menatetrenone (vitamin K2) decreased serum undercarboxylated osteocalcin concentration, decreased bone resorption and increased BMD. Sunlight exposure (men and women), menatetrenone (women), alendronate and risedronate with vitamin D supplementation (women) significantly reduced the incidence of hip fractures. The respective RRs (95% confidence intervals) according to the intention-to-treat analysis were 0.27 (0.08, 0.96), 0.13 (0.02, 0.97), 0.29 (0.10, 0.85) and 0.20 (0.06, 0.68). Interventions, including sunlight exposure, menatetrenone and oral bisphosphonates with vitamin D supplementation, have a protective effect against hip fractures elderly patients with Parkinson’s disease.
Vitamin D; Vitamin K; Hip fractures; Parkinson’s disease; Mortality
OBJECTIVE: To review the evidence concerning alendronate (Fosamax) therapy for postmenopausal osteoporosis. QUALITY OF EVIDENCE: The efficacy of alendronate for postmenopausal women with osteoporosis was primarily demonstrated by two primary phase III clinical trials, three other 2-year trials, and one 3-year trial. All six trials were randomized double-blind placebo-controlled trials; 3854 postmenopausal women were studied. The Fracture Intervention Trial consisted of 2027 women with postmenopausal osteoporosis and provides the most evidence that 3 years of treatment with alendronate reduces all clinically relevant fractures, including hip fractures. MAIN FINDINGS: In postmenopausal women, alendronate has been shown to increase bone mineral density significantly at the lumbar spine, femoral neck, and trochanter and in the total body, regardless of baseline bone mineral density, age, bone turnover, or the presence of previous fractures. In addition, alendronate has been shown to reduce risk of new vertebral and hip fractures by about 50% and of all clinical fractures by about 30%. Continuous daily dosing with alendronate (10 mg) was found to be well tolerated. In addition, alendronate was shown to have no adverse effects on bone mineralization or microstructure. CONCLUSION: This evidence shows alendronate to be safe and effective; it should be considered the nonhormonal therapy of choice for treating osteoporosis in postmenopausal women at risk for hip and vertebral fractures.