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There is a great interest in examining the evidence for an interaction of FRAX® probabilities with drug efficacy. A recent article from Kanis and colleagues [1] has evaluated the distribution of fracture risk assessed at baseline using the FRAX tool in the MORE study and has determined the efficacy of raloxifene as a function of baseline fracture risk. 

 

They concluded that raloxifene (both 60 and 120 mg doses) significantly decreased the risk of all clinical fractures (18%; hazard ratio (HR )  0.82; 95% confidence interval (CI) 0.71–0.95; [i]p[/i] = 0.0063) and morphometric vertebral fractures (42%; HR 0.58; 95% CI 0.48–0.69; [i]p[/i] = 0.001). Efficacy was shown over the whole range of fracture probability and the interaction between fracture probability and treatment was not significant.

Author(s)

  • Santiago Palacios
    Director of the Palacios Institute of Womens Health, Madrid, Spain

Citations

  1. Kanis JA, Johansson H, Oden A, et al. A meta-analysis of the efficacy of raloxifene on all clinical and vertebral fractures and its dependency on FRAX. Bone 2010;47:729-35.
    http://www.ncbi.nlm.nih.gov/pubmed/20601292
  2. Kanis JA, on behalf of the World Health Organization Scientific Group. Assessment of osteoporosis at the primary health-care level. WHO Collaborating Centre for Metabolic Bone Diseases, University of Sheffield, UK, 2007.
    http://www.shef.ac.uk/FRAX/pdfs/WHO_Technical_Report.pdf
  3. Kanis JA, Johnell O, Oden A, et al. FRAX and the assessment of fracture probability in men and women from the UK. Osteoporos Int 2008;19:385-97.
    http://www.ncbi.nlm.nih.gov/pubmed/18292978
  4. Kanis JA, Johansson H, Oden A, McCloskey EV. Bazedoxifene reduces vertebral and clinical fractures in postmenopausal women at high risk assessed with FRAX. Bone 2009;44:1049-54.
    http://www.ncbi.nlm.nih.gov/pubmed/19254788
  5. McCloskey EV, Johansson H, Oden A, et al. Ten-year fracture probability identifies women who will benefit from clodronate therapy additional results from a double-lind, placebo-controlled randomised study. Osteoporos Int 2009;20:811-17.
    http://www.ncbi.nlm.nih.gov/pubmed/19002369
  6. Ettinger B, Black DM, Mitlak BH, et al. Reduction of vertebral fracture risk in postmenopausal women with osteoporosis treated with raloxifene: results from a 3-year randomized clinical trial. Multiple Outcomes of Raloxifene Evaluation (MORE) Investigators. JAMA 1999;282:637-45.
    http://www.ncbi.nlm.nih.gov/pubmed/10517716

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