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Primary study

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Direct health-care costs attributed to hip fractures among seniors: a matched cohort study.

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Journal Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA
Year 2013
Links Pubmed DOI PubMed Central

This article is included in 1 Broad synthesis Broad syntheses (1 reference)

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SUMMARY: Using a matched cohort design, we estimated the mean direct attributable cost in the first year after hip fracture in Ontario to be $36,929 among women and $39,479 among men. These estimates translate into an annual $282 million in direct attributable health-care costs in Ontario and $1.1 billion in Canada. INTRODUCTION: Osteoporosis is a major public health concern that results in substantial fracture-related morbidity and mortality. It is well established that hip fractures are the most devastating consequence of osteoporosis, yet the health-care costs attributed to hip fractures in Canada have not been thoroughly evaluated. METHODS: We determined the 1- and 2-year direct attributable costs and cost drivers associated with hip fractures among seniors in comparison to a matched non-hip fracture cohort using health-care administrative data from Ontario (2004-2008). Entry into long-term care and deaths attributable to hip fracture were also determined. RESULTS: We successfully matched 22,418 female (mean age = 83.3 years) and 7,611 male (mean age = 81.3 years) hip fracture patients. The mean attributable cost in the first year after fracture was $36,929 (95 % CI $36,380-37,466) among women and $39,479 (95 % CI $38,311-$40,677) among men. These estimates translate into an annual $282 million in direct attributable health-care costs in Ontario and $1.1 billion in Canada. Primary cost drivers were acute and post-acute institutional care. Approximately 24 % of women and 19 % of men living in the community at the time of fracture entered a long-term care facility, and 22 % of women and 33 % of men died within the first year following hip fracture. Attributable costs remained elevated into the second year ($9,017 among women, $10,347 among men) for patients who survived the first year. CONCLUSIONS: We identified significant health-care costs, entry into long-term care, and mortality attributed to hip fractures. Results may inform health economic analyses and policy decision-making in Canada.

Primary study

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Raloxifene and Tibolone in Elderly Women: A Randomized, Double-Blind, Double-Dummy, Placebo-Controlled Trial.

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Journal Journal of the American Medical Directors Association
Year 2012
Links Pubmed DOI

This article is included in 1 Broad synthesis Broad syntheses (1 reference) 2 Systematic reviews Systematic reviews (2 references)

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Abstract: OBJECTIVES: The authors’ first aim was to study the effects of raloxifene and tibolone on body mass density, handgrip strength, and other secondary frailty components. The secondary aim was to compare the effects of raloxifene and tibolone and their safety in older women. Design/Setting/Participants: A randomized, double-blind, double- dummy, placebo-controlled trial conducted in an academic hospital in the Netherlands among 318 community living women aged >70 were randomized; 290 received the allocated intervention: 97 placebo, 101 raloxifene, and 92 tibolone. INTERVENTIONS: Randomization was made to raloxifene 60 mg, tibolone 1.25 mg, or placebo. Assessments were performed at baseline and after 3, 6, 12, and 24 months. The study was conducted from July 2003 to January 2008. The tibolone group stopped earlier in February 2006, because of results of the Long-Term Intervention on Fractures with Tibolone study, suggesting an increased risk of cerebrovascular accident. Measurements: Primary endpoints were body mass density and handgrip strength. Secondary endpoints were muscle power and strength, mobility measures, body composition, verbal memory, mental processing speed, anxiety, mood, and quality of life. RESULTS: Tibolone and raloxifene had similar body mass density-effect sizes (d = .24–.47), and had no effect on handgrip muscle strength. For the 15 words test the effect on direct recall of concrete and abstract words (d = .40 and d =.27, respectively) and on delayed recall of concrete words (d = .77) were significantly higher in the raloxifene group compared to placebo and to tibolone. In the raloxifene group the health status (EuroQol VAS (0–100) was improved 2.4 points [95% CI 0.5–4.2; P = .012] over 24 months. CONCLUSION: In women >70 years old, raloxifene and tibolone significantly and similarly increased body mass density but not muscle strength. Raloxifene had also positive effects on verbal memory and health status. New research with selective estrogen receptor modulators like raloxifene might be promising on frailty endpoints in elderly women. Trial registration number: Nederlands Trial Register: 1232

Publication Thread

Cameron 2011

This thread includes 3 references

Publication Thread

Cameron et al, 2011a

This thread includes 3 references

Publication Thread

FREEDOM (Fracture REduction Evaluation of Denosumab in Osteoporosis every 6 Months)

This thread includes 12 references

Primary study

Unclassified

Recovery of function following a hip fracture in geriatric ambulatory persons living in nursing homes: prospective cohort study.

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Journal Journal of the American Geriatrics Society
Year 2012
Links Pubmed DOI

This article is included in 1 Broad synthesis Broad syntheses (1 reference)

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OBJECTIVES: To measure 1-year post-hip fracture functional recovery, health-related quality of life (HRQL), and mortality in nursing home residents. DESIGN: Prospective longitudinal cohort study. SETTING AND PARTICIPANTS: Ambulatory nursing home residents with or without impaired cognition consecutively admitted with hip fracture to three Canadian tertiary-care hospitals from March 2008 through November 2009. MEASUREMENTS: Participants or proxy respondents completed the Functional Independence Measure Motor score (FIM(motor) ) and EuroQol5D index score (EQ-5D(index) ) in the hospital (prefracture status) and 3, 6, and 12 months after fracture. Complications over the first postfracture year were also ascertained; the primary outcome was functional recovery (change in FIM(motor) score). RESULTS: Of 92 eligible participants, 60 (64%) were enrolled. The mean age was 86.9 ± 8.1, 42 (70%) were female, and 45 (75%) had three or more comorbidities. Forty-three (72%) walked independently with or without aids before fracture. By 12 months, 27 (45%) participants had died, and 10 (17%) had withdrawn. Of the remaining 23 participants, functional status according to FIM(motor) score dropped substantially and significantly after the fracture (3 months, 34.0 ± 19.7; 6 months, 33.2 ± 19.7; 12 months, 32.0 ± 20.0; P < .001 from a baseline FIM(motor) score of 50.1 ± 16.1). By 12 months after the fracture, only eight (35%) were walking independently, and 11 (48%) were no longer ambulatory. HRQL according to the EQ-5D(index) also decreased significantly (P = .003), from 0.62 ± 0.20 before fracture to 0.42 ± 0.30 by 12 months after fracture. CONCLUSION: Hip fracture for nursing home residents was associated with substantial loss of functional independence, ambulation, and HRQL. Little recovery was evident after the first 3 months; there was almost 50% mortality within 12 months.

Publication Thread

ROSE study (Rapid Onset and Sustained Efficacy)

This thread includes 2 references

Systematic review

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Calcium supplements with or without vitamin D and risk of cardiovascular events: reanalysis of the Women's Health Initiative limited access dataset and meta-analysis.

Journal BMJ (Clinical research ed.)
Year 2011
Links Pubmed DOI PubMed Central

Without references

This article is included in 1 Structured summary of primary studies 0 Structured summaries of primary studies (1 reference) 1 Broad synthesis 0 Broad syntheses (1 reference)

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OBJECTIVES: To investigate the effects of personal calcium supplement use on cardiovascular risk in the Women's Health Initiative Calcium/Vitamin D Supplementation Study (WHI CaD Study), using the WHI dataset, and to update the recent meta-analysis of calcium supplements and cardiovascular risk. DESIGN: Reanalysis of WHI CaD Study limited access dataset and incorporation in meta-analysis with eight other studies. Data source WHI CaD Study, a seven year, randomised, placebo controlled trial of calcium and vitamin D (1g calcium and 400 IU vitamin D daily) in 36,282 community dwelling postmenopausal women. Main outcome measures Incidence of four cardiovascular events and their combinations (myocardial infarction, coronary revascularisation, death from coronary heart disease, and stroke) assessed with patient-level data and trial-level data. RESULTS: In the WHI CaD Study there was an interaction between personal use of calcium supplements and allocated calcium and vitamin D for cardiovascular events. In the 16,718 women (46%) who were not taking personal calcium supplements at randomisation the hazard ratios for cardiovascular events with calcium and vitamin D ranged from 1.13 to 1.22 (P = 0.05 for clinical myocardial infarction or stroke, P = 0.04 for clinical myocardial infarction or revascularisation), whereas in the women taking personal calcium supplements cardiovascular risk did not alter with allocation to calcium and vitamin D. In meta-analyses of three placebo controlled trials, calcium and vitamin D increased the risk of myocardial infarction (relative risk 1.21 (95% confidence interval 1.01 to 1.44), P = 0.04), stroke (1.20 (1.00 to 1.43), P = 0.05), and the composite of myocardial infarction or stroke (1.16 (1.02 to 1.32), P = 0.02). In meta-analyses of placebo controlled trials of calcium or calcium and vitamin D, complete trial-level data were available for 28,072 participants from eight trials of calcium supplements and the WHI CaD participants not taking personal calcium supplements. In total 1384 individuals had an incident myocardial infarction or stroke. Calcium or calcium and vitamin D increased the risk of myocardial infarction (relative risk 1.24 (1.07 to 1.45), P = 0.004) and the composite of myocardial infarction or stroke (1.15 (1.03 to 1.27), P = 0.009). CONCLUSIONS: Calcium supplements with or without vitamin D modestly increase the risk of cardiovascular events, especially myocardial infarction, a finding obscured in the WHI CaD Study by the widespread use of personal calcium supplements. A reassessment of the role of calcium supplements in osteoporosis management is warranted.

Primary study

Unclassified

Health-related quality of life and treatment of postmenopausal osteoporosis: results from the HORIZON-PFT.

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Journal Bone
Year 2011
Links Pubmed DOI

This article is included in 1 Broad synthesis Broad syntheses (1 reference)

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Osteoporosis-related fractures are associated with reductions in health-related quality of life (HRQL). We examined the benefits of zoledronic acid (ZOL) on HRQL in patients sustaining vertebral and clinical fractures from HORIZON-Pivotal Fracture Trial using mini-Osteoporosis quality of life Questionnaire (OQLQ). In this multicenter, double-blind, placebo-controlled trial, 1434 patients from a cohort of postmenopausal women with osteoporosis (mean age 73years) were randomized to receive annual infusions of ZOL 5mg or placebo for 3years. Baseline HRQL scores were comparable between ZOL and placebo groups based on the presence or absence of fractures, with exception of prevalent vertebral fractures where patients (irrespective of the treatment group) had lower baseline HRQL scores than those without prevalent vertebral fractures. Greater number of prevalent vertebral fractures was associated with lower baseline HRQL (p<0.001). No significant difference between ZOL and placebo in the overall summary score was observed but a significant benefit was noted in certain domains with ZOL, especially in patients sustaining incident clinical fractures. Improvements in HRQL were marked at first assessment after a morphometric vertebral fracture with significant differences favouring ZOL in pain (p=0.0115), standing pain (p=0.0125)), physical (lifting, p=0.0333) and emotional function (fear of fractures, p=0.0243; fear of falls, p=0.0075) but not for activities of daily living or leisure domains. HRQL is reduced in patients with vertebral fractures. Treatment with ZOL over 3years was associated with improvements in specific domains of quality of life vs. placebo, particularly in patients sustaining incident fractures.

Primary study

Unclassified

Effect of Raloxifene on All-cause Mortality

Journal The American journal of medicine
Year 2010
Links Pubmed DOI

This article is included in 2 Systematic reviews Systematic reviews (2 references) 1 Broad synthesis Broad syntheses (1 reference)

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Objective: Raloxifene, a selective estrogen receptor modulator, reduces osteoporosis and invasive breast cancer risk but increases risk for venous thromboembolism and fatal stroke in women with or at high risk for coronary heart disease. To assess the risk/benefit of raloxifene as a preventative treatment, we analyzed treatment effects on overall and cause-specific mortality. Methods: A pooled analysis of mortality data was performed from large clinical trials of raloxifene (60 mg/day) versus placebo, including the Multiple Outcomes of Raloxifene Evaluation/Continuing Outcomes Relevant to Evista studies (7705 postmenopausal osteoporotic women followed for 4 years and a subset of 4011 participants followed for an additional 4 years; 110 deaths) and the Raloxifene Use for the Heart trial (10,101 postmenopausal women with coronary disease or multiple risk factors for coronary disease followed for 5.6 years; 1149 deaths). Cause of death was assessed by blinded adjudicators. Cox proportional hazards regression models compared mortality by treatment assignment in a pooled analysis of trial data from the Multiple Outcomes of Raloxifene Evaluation/Continuing Outcomes Relevant to Evista and Raloxifene Use for the Heart trials. Results: All-cause mortality was 10% lower among women assigned to raloxifene 60 mg/day versus placebo (relative hazard 0.90; 95% confidence interval, 0.80-1.00; P = .05). Lower overall mortality was primarily due to lower rates of noncardiovascular deaths, especially a lower rate of noncardiovascular, noncancer deaths. Conclusions: All-cause mortality was 10% lower in pooled analyses among older postmenopausal women receiving raloxifene 60 mg/day compared with placebo, due primarily to a reduction in noncardiovascular, noncancer deaths. The mechanism whereby raloxifene might reduce the risk of noncardiovascular death is unclear.