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Osteoporosis International

, Volume 16, Issue 10, pp 1291–1298 | Cite as

Effect of osteoporosis treatments on risk of non-vertebral fractures: review and meta-analysis of intention-to-treat studies

  • Steven Boonen
  • Roland F. Laan
  • Ian P. Barton
  • Nelson B. Watts
Original Article

Abstract

Most osteoporosis treatments have proven efficacy in reducing the risk of vertebral fractures, whereas evidence is less straightforward for prevention of non-vertebral fractures. Conclusions as to the efficacy of a treatment should be based primarily on analyses of the intention to treat (ITT) population rather than on exploratory subgroup analyses; however, non-vertebral anti-fracture efficacy has been largely derived by post-hoc subgroup analyses. This review and meta-analysis was performed to assess non-vertebral anti-fracture efficacy of several osteoporosis therapies, including a more stringent assessment of the ITT populations. Data on non-vertebral anti-fracture efficacy, a defined endpoint of the ITT analyses and confirmed by radiographs, were obtained from randomized, placebo-controlled, phase III clinical trials of at least 3-year duration. Meta-analyses were performed for the two bisphosphonates, alendronate and risedronate. Relative risks (RR), 95% confidence intervals (CI) and statistical significance for active treatment compared with placebo were calculated. Eleven clinical trials met the criteria for review, three of which showed statistically significant ( P ≤0.05) non-vertebral anti-fracture efficacy in the ITT population: two trials with risedronate and one trial with strontium. A meta-analysis showed significant reductions in the relative risk of non-vertebral fracture for both alendronate (RR=0.86; 95% CI: 0.76–0.97, P =0.012) and risedronate (RR=0.81; 95% CI: 0.71–0.92, P =0.001). Risedronate and strontium ranelate were the only treatments to show non-vertebral anti-fracture efficacy in this robust assessment of anti-fracture efficacy of osteoporosis therapy using ITT populations in trials of 3 years or more in duration. Risedronate was the only agent shown to demonstrate efficacy in more than one trial. Meta-analysis showed that both alendronate and risedronate provide non-vertebral anti-fracture efficacy.

Keywords

Alendronate Ibandronate Non-vertebral fracture Raloxifene Risedronate Strontium ranelate 

Notes

Acknowledgements

Dr. S. Boonen is senior clinical investigator of the Fund for Scientific Research, Flanders, Belgium (F.W.O., Vlaanderen) and holder of the Leuven University Chair for Metabolic Bone Diseases. This study was supported by grant G.0171.03 N from the Fund for Scientific Research, Flanders, Belgium (F.W.O., Vlaanderen). The authors thank Christine Gilchrist for performing the Medline, EMBASE and BIOL electronic literature searches.

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Copyright information

© International Osteoporosis Foundation and National Osteoporosis Foundation 2005

Authors and Affiliations

  • Steven Boonen
    • 1
  • Roland F. Laan
    • 2
  • Ian P. Barton
    • 3
  • Nelson B. Watts
    • 4
  1. 1.Division of Geriatric Medicine, Center for Metabolic Bone DiseasesCatholic University of LeuvenLeuvenBelgium
  2. 2.Department of RheumatologyRadboud University Nijmegen Medical CenterNijmegenThe Netherlands
  3. 3.Procter and Gamble PharmaceuticalsEghamUK
  4. 4.College of MedicineUniversity of CincinnatiCincinnatiUSA

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