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Treatment To Prevent Fractures in Men and Women With Low Bone Density or Osteoporosis: Update of a 2007 Report
Comparative Effectiveness Reviews, No. 53
Investigators: Carolyn J Crandall, MD, MS, Sydne J Newberry, PhD, Allison Diamant, MD, MSHS, Yee-Wei Lim, MD, PhD, Walid F Gellad, MD, MPH, Marika J Suttorp, MS, Aneesa Motala, BA, Brett Ewing, MS, Beth Roth, MA, Roberta Shanman, MLS, Martha Timmer, MS, and Paul G Shekelle, MD, PhD.
Author Information and AffiliationsStructured Abstract
Objectives:
To update a 2007 systematic review on the effectiveness and safety of treatments to prevent fractures in persons with low bone density or osteoporosis and factors affecting adherence to these treatments, and to assess whether monitoring helps identify those most likely to benefit from treatment and the benefits of long-term treatment.
Data Sources:
MEDLINE®, Embase, the Cochrane Database of Systematic Reviews, and Clinical Trials.gov were searched from January 2005 through March 2011.
Review Methods:
After review by two investigators against predetermined inclusion/exclusion criteria, we included existing systematic reviews, randomized controlled clinical trials, and large observational studies, where appropriate, for assessment of treatment efficacy, safety, and adherence.
Results:
Alendronate, risedronate, zoledronic acid, denosumab, and teriparatide reduce the risk of vertebral and nonvertebral fractures among postmenopausal women with osteoporosis. Ibandronate and raloxifene reduce the risk of vertebral but not nonvertebral fractures. Alendronate, risedronate, zoledronic acid, and denosumab prevent hip fractures among postmenopausal women with osteoporosis. Risedronate decreases the risk of vertebral and nonvertebral fracture among men with osteoporosis.
Among those treated with glucocorticoids, fracture risk reduction was demonstrated for risedronate and alendronate compared to placebo; and for teriparatide compared to alendronate.
Few studies have compared osteoporosis therapies head-to-head.
Adherence to pharmacotherapy is poor in patients with osteoporosis, as with other chronic conditions. Many factors affect adherence to medications, including dosing frequency, side effects of medications, knowledge about osteoporosis, and cost. Age, prior history of fracture, and concomitant medication use do not appear to have an independent association with adherence. Dosing frequency appears to affect adherence: Adherence is improved with weekly compared to daily regimens, but evidence is lacking to show that monthly regimens improve adherence over that of weekly regimens. Decreased adherence to bisphosphonates is associated with less than optimal reduction in the risk of fracture. Insufficient evidence is available to make conclusions about how adherence to and persistence with newer osteoporosis therapies compare to that with bisphosphonates.
Assessment of adverse effects finds that raloxifene is associated with an increased risk for pulmonary embolism and vasomotor flushing; and limited data support a possible association between bisphosphonate use and atypical subtrochanteric fractures of the femur. Evidence is limited on the utility of monitoring and long-term treatment.
Conclusions:
There is a high level of evidence that shows that fracture risk reduction is greatest in women with a diagnosis of osteoporosis and/or prevalent fractures. The level of evidence is low to moderate for fracture risk reduction in postmenopausal women with osteopenia and without prevalent fractures. The evidence is low for benefits of treatment for other populations, including men; for the benefits and risks of long-term treatment; and for the need (if any) for monitoring bone density; and mixed with regard to factors that influence adherence.
Contents
- Preface
- Acknowledgments
- Technical Expert Panel
- Peer Reviewers
- Executive Summary
- Introduction
- Methods
- Results
- Literature Search
- Key Question 1. What Are the Comparative Benefits in Fracture Risk Reduction Among the Following Therapeutic Modalities for low Bone Density: Bisphosphonates, Denosumab, Menopausal Hormone Therapy, Selective Estrogen Receptor Modulators (Raloxifene), Parathyroid Hormone, Calcium, Vitamin D, and Physical Activity?
- Key Question 2. How Does Fracture Risk Reduction Resulting From Treatments Vary Between Individuals With Different Risks for Fracture as Determined by Bone Mineral Density, FRAX or Other Risk Assessment Score, Prior Fractures, age, sex, Race/Ethnicity and Glucocorticoid use, and Other Factors (e.g., Community Dwelling vs. Institutionalized, Vitamin D Deficient vs. not)?
- Key Question 3. Regarding Treatment Adherence and Persistence: a) What are the Adherence and Persistence With Medications for the Treatment and Prevention of Osteoporosis? b) What Factors Affect Adherence and Persistence? c) What are 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 Above Therapies (When Used Specifically To Treat or Prevent low Bone Density/Osteoporotic Fracture), and do These Vary by any Specific Subpopulations (e.g., the Subpopulations Identified in Key Question 2)?
- Key Question 5. With Regard to Treatment for Preventing Osteoporotic Fracture: a) How Often Should Patients be Monitored (via Measurement of Bone Mineral Density) During Therapy, how Does Bone Density Monitoring Predict Antifracture Benefits During Pharmacotherapy, and Does the Ability of Monitoring to Predict Antifracture Effects of a Particular Pharmacologic Agent Vary Among the Pharmacotherapies? b) How Does the Antifracture Benefit Vary With Long-term Continued use of Pharmacotherapy, and What are the Comparative Antifracture Effects of Continued Long-term Therapy With the Various Pharmacotherapies?
- Summary and Discussion
- Conclusions
- Discussion
- Future Research
- References
- Abbreviations
- Appendixes
Note: Several studies in this report have been retracted. They are indicated in the References section. More information is located on the journals’ websites and the Retraction Watch database.
Suggested citation:
Crandall CJ, Newberry SJ, Gellad WG, Diamant A, Lim YW, Suttorp M, Motala A, Ewing B, Roth B, Timmer M, Shanman R, Shekelle PG. Treatment to Prevent Fractures in Men and Women with Low Bone Density or Osteoporosis: Update of a 2007 Report. Comparative Effectiveness Review No. 53. (Prepared by Southern California Evidence-based Practice Center under Contract No. HHSA-290-2007-10062-I.) Rockville, MD: Agency for Healthcare Research and Quality; March 2012. www.effectivehealthcare.ahrq.gov/reports/final.cfm.
This report is based on research conducted by the Southern California Evidence-based Practice Center under contract to the Agency for Healthcare Research and Quality (AHRQ), Rockville, MD, under Contract No. HHSA-290-2001-10062-I. The findings and conclusions in this document are those of the authors, 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 AHRQ or of the U.S. Department of Health and Human Services.
The information in this report is intended to help health care decisionmakers—patients and clinicians, health system leaders, and policymakers, among others—make well-informed decisions and thereby improve the quality of health care services. This report is not intended to be a substitute for the application of 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, i.e., in the context of available resources and circumstances presented by individual patients.
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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- Summary of AHRQ's comparative effectiveness review of treatment to prevent fractures in men and women with low bone density or osteoporosis: update of the 2007 report.[J Manag Care Pharm. 2012]Summary of AHRQ's comparative effectiveness review of treatment to prevent fractures in men and women with low bone density or osteoporosis: update of the 2007 report.Levis S, Theodore G. J Manag Care Pharm. 2012 May; 18(4 Suppl B):S1-15; discussion S13.
- Indirect comparison of teriparatide, denosumab, and oral bisphosphonates for the prevention of vertebral and nonvertebral fractures in postmenopausal women with osteoporosis.[Menopause. 2015]Indirect comparison of teriparatide, denosumab, and oral bisphosphonates for the prevention of vertebral and nonvertebral fractures in postmenopausal women with osteoporosis.Zhang L, Pang Y, Shi Y, Xu M, Xu X, Zhang J, Ji L, Zhao D. Menopause. 2015 Sep; 22(9):1021-5.
- Bisphosphonate alternative regimens for the prevention of osteoporotic fragility fractures: BLAST-OFF, a mixed-methods study.[Health Technol Assess. 2024]Bisphosphonate alternative regimens for the prevention of osteoporotic fragility fractures: BLAST-OFF, a mixed-methods study.Sahota O, Narayanasamy M, Bastounis A, Paskins Z, Bishop S, Langley T, Gittoes N, Davis S, Baily A, Holmes M, et al. Health Technol Assess. 2024 Apr; 28(21):1-169.
- Review Screening to Prevent Osteoporotic Fractures: An Evidence Review for the U.S. Preventive Services Task Force[ 2018]Review Screening to Prevent Osteoporotic Fractures: An Evidence Review for the U.S. Preventive Services Task ForceViswanathan M, Reddy S, Berkman N, Cullen K, Middleton JC, Nicholson WK, Kahwati LC. 2018 Jun
- Review Comparative efficacy of bisphosphonates in short-term fracture prevention for primary osteoporosis: a systematic review with network meta-analyses.[Osteoporos Int. 2016]Review Comparative efficacy of bisphosphonates in short-term fracture prevention for primary osteoporosis: a systematic review with network meta-analyses.Zhou J, Ma X, Wang T, Zhai S. Osteoporos Int. 2016 Nov; 27(11):3289-3300. Epub 2016 Jun 7.
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