Excerpt

This Comparative Effectiveness Review (CER) compares the benefits in fracture reduction and the harms from adverse events (AE) among and within the various classes of treatment for low bone density. Our outcomes of interest for measuring benefits are vertebral, non-vertebral, hip, and radial fractures. The studies collect vertebral fracture outcomes in one of two ways. In some studies, all participants undergo radiography at pre-determined intervals. Other studies use clinical criteria, i.e. whether a fracture has been diagnosed by a clinician during the time interval. Trials that radiograph all participants will by nature detect more fractures. However the higher detection rate will apply to both treatment and placebo groups. Thus, the relative differences found should be similar that found in studies that use clinical criteria.

Contents

• Preface
• Acknowledgments
• Executive Summary
• 1. Introduction
  • Background
  • Definition of Osteoporosis
  • Risk Factors for Low BMD, Osteoporosis, and Fractures
  • Treatment and Prevention of Osteoporosis
  • This Report
  • Scope and Key Questions
• 2. Methods
  • Topic Development and Technical Expert Panel
  • Search Strategy
  • Study Selection
  • Data Extraction
  • Quality Assessment
  • Applicability
  • Rating the Body of Evidence
  • Data Synthesis
  • Peer Review
• 3. Results
  • Key Question 1. What are the comparative benefits in fracture reduction among and also within the following treatments for low bone density
  • Key Question 2. How does fracture reduction resulting from treatments vary between individuals with different risks for fracture as determined by bone mineral density (borderline/low/severe), prior fractures (prevention vs. treatment), age, gender, glucocorticoid use, and other factors (e.g., community dwelling vs. institutionalized; vitamin D deficient vs. not)?
  • Key Question 3. What are the adherence to and persistence with medications for the treatment and prevention of osteoporosis, the factors that affect adherence and persistence, and the effects of adherence and persistence on the risk of fractures?
  • Key Question 4. What are the short- and long-term harms (adverse effects) of the therapies, and do these vary by any specific subpopulations?
• 4. Summary and Discussion
  • Limitations
  • Conclusions
  • Discussion
• 5. Future Research
• Abbreviations
• Appendixes
  • Appendix A. Search Strategy
  • Appendix B. Data Abstraction Forms
  • Appendix C. Evidence Tables
  • Appendix D. Excluded Studies
  • Appendix E. Adverse Events Analyses
• References

Suggested citation:

MacLean C, Alexander A, Carter J, Chen S, Desai SB, Grossman J, Maglione M, McMahon M, McNamara M, Mojica W, Newberry S, Ranganath V, Suttorp M, Timmer M, Tringale C, Valentine D, Zhou A. Comparative Effectiveness of Treatments To Prevent Fractures in Men and Women With Low Bone Density or Osteoporosis. Comparative Effectiveness Review No. 12. (Prepared by Southern California/RAND Evidence-based Practice Center under Contract No. 290-02-0003). Rockville, MD: Agency for Healthcare Research and Quality. December 2007. Available at: http://effectivehealthcare.ahrq.gov/healthInfo.cfm?infotype=all&reptype=allfinal.

This report is based on research conducted by the Southern California/RAND Evidence-based Practice Center (EPC) under contract to the Agency for Healthcare Research and Quality (AHRQ), Rockville, MD (Contract No. 290-02-0003). The findings and conclusions in this document are those of the author(s), who are responsible for its contents; the findings and conclusions do not necessarily represent the views of AHRQ. Therefore, no statement in this report should be construed as an official position of the Agency for Healthcare Research and Quality or of the U.S. Department of Health and Human Services.

This report is intended as a reference and not as a substitute for clinical judgment. Anyone who makes decisions concerning the provision of clinical care should consider this report in the same way as any medical reference and in conjunction with all other pertinent information.

This report may be used, in whole or in part, as the basis for development of clinical practice guidelines and other quality enhancement tools, or as a basis for reimbursement and coverage policies. AHRQ or U.S. Department of Health and Human Services endorsement of such derivative products may not be stated or implied.

None of the investigators has any affiliations or financial involvement that conflicts with the material presented in this report.

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