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Treatment To Prevent Fractures in Men and Women With Low Bone Density or Osteoporosis: Update of a 2007 Report [Internet]

Treatment To Prevent Fractures in Men and Women With Low Bone Density or Osteoporosis: Update of a 2007 Report [Internet]

Comparative Effectiveness Reviews - Agency for Healthcare Research and Quality (US)

Version: March 2012

Discussion

This report provides a comprehensive summary of the systematic reviews and RCTs that evaluated the effect of various agents on fracture risk. Across these studies there is a high level of evidence that alendronate, risedronate, ibandronate, zoledronic acid, raloxifene, denosumab, and teriparatide each reduce the risk of vertebral fractures among postmenopausal women with osteoporosis. A high level of evidence shows that alendronate, risedronate, zoledronic acid, and denosumab each reduce the risk of nonvertebral fractures among postmenopausal women with osteoporosis. There is a high level of evidence that alendronate, risedronate, denosumab, and zoledronic acid each decrease the risk of hip fractures among postmenopausal women with osteoporosis. A high level of evidence supports the effectiveness of menopausal hormone therapy in decreasing vertebral fracture and hip fracture risk, and the effectiveness of teriparatide in reducing nonvertebral fracture risk. Accordingly, each of these agents is FDA-approved for therapy of osteoporosis. Studies directly comparing the antifracture effects among various bisphosphonates are few and do not provide conclusive evidence supporting the effectiveness of one bisphosphonate over another, despite some basic scientific evidence for why they might differ. Neither is there evidence for statistically significant differences in the effects of bisphosphonates compared to raloxifene, teriparatide, or menopausal hormone therapy. Multiple RCTs do not demonstrate the effectiveness of calcium alone in reducing risk of vertebral, nonvertebral, or hip fractures. However it is critical to note that the currently approved prescription osteoporosis therapies are only proven efficacious in RCTs that administered concurrent calcium and vitamin D. A moderate level of evidence supports the effectiveness of vitamin D in combination with calcium in reducing hip fracture risk among institutionalized persons. No RCTs of exercise interventions have demonstrated a reduction in fracture risk.

Conclusions

With the above limitations in mind, we reached the conclusions displayed in the table below (Table 57). Changes in conclusion in this report, compared to the 2007 report are presented in bold.

Introduction

Osteoporosis is a systemic skeletal disease characterized by decreasing bone mass and microarchitectural deterioration of bone tissue, with consequent increases in bone fragility and susceptibility to fracture. In addition to fractures, the clinical complications of osteoporosis include disability and chronic pain. Approximately 52 million people in the United States are affected by osteoporosis or low bone density. It is especially common in postmenopausal women, but one in five men will experience an osteoporosis-related fracture at some point in his lifetime.

Executive Summary

Osteoporosis is a systemic skeletal disease characterized by decreasing bone mass and microarchitectural deterioration of bone tissue, with consequent increases in bone fragility and susceptibility to fracture. In addition to fractures, the clinical complications of osteoporosis include disability and chronic pain. Approximately 52 million people in the United States are affected by osteoporosis or low bone density. It is especially common in postmenopausal women, but one in five men will experience an osteoporosis-related fracture at some point in his lifetime.

Results

The initial searches done in September 2009 covering the period from January 2005-December 2009 found a total of 18,667 titles. A further search was done on PubMed alerts which produced 178 total citations. Reference mining contributed an additional 217 citations. In October and November 2010 an update search was done and then a final update search was done in March 2011 which produced a total of 7,304 hits. All 26,366 citations were imported into EndNote and screened. In total, reviewers selected 2,440 relevant titles for abstract review out of 26,366 titles identified in the searches (see Figure 2). Abstract review resulted in rejection of 1,644 articles. Reasons for abstract exclusion included the following: articles were not on osteoporosis (535), design (772), fracture not reported (only in effectiveness analyses) (262), population (75). Eight articles were not found, and 127 were already in the original report. Thus, 661 full-text articles were available for the next stage of screening (short form).

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