Efficacy of raloxifene on vertebral fracture risk reduction in postmenopausal women with osteoporosis: Four-year results from a randomized clinical trial

Pierre D. Delmas, Kristine E. Ensrud, Jonathan D. Adachi, Kristine D. Harper, Somnath Sarkar, Carlo Gennari, Jean Yves Reginster, Huibert A.P. Pols, Robert R. Recker, Steven T. Harris, Wentao Wu, Harry K. Genant, Dennis M. Black, Richard Eastell

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Abstract

The Multiple Outcomes of Raloxifene Evaluation trial studied 7705 postmenopausal women with osteoporosis randomized to placebo, or raloxifene 60 or 120 mg/d [JAMA 282(1999):637]. This report assesses the efficacy of raloxifene on the long-term cumulative incidence new vertebral fractures through 4 yr. New vertebral fractures was assessed from radiographs taken at baseline, yr 2-4. The primary analysis was the cumulative incidence of new vertebral fractures through 4 yr. A posthoc analysis compared the vertebral fracture risk in yr 4 alone with that observed in the first 3 yr. The 4-yr cumulative relative risks (RR) for one or more new vertebral fractures were 0.64 [95% confidence interval (CI) 0.53, 0.76] with raloxifene 60 mg/d and 0.57 (95% CI 0.48, 0.69) with raloxifene 120 mg/d. In yr 4 alone, raloxifene 60 mg/d reduced the new vertebral fracture risk by 39% [RR 0.61 (95% CI 0.43, 0.88)], which was not found to be significantly different from the RR observed in the first 3 yr in both raloxifene groups, irrespective of prevalent fracture status. The nonvertebral fracture risk was not significantly reduced [RR 0.93 (95% CI 0.81, 1.06)]. The safety profile after 4 yr was similar to that observed after 3 yr. Raloxifene 60 and 120 mg/d through 4 yr decreased the cumulative risk of new vertebral fractures in postmenopausal women with osteoporosis. The decreased vertebral fracture risk in yr 4 alone was not different from that observed in the first 3 yr.

Original languageEnglish (US)
Pages (from-to)3609-3617
Number of pages9
JournalJournal of Clinical Endocrinology and Metabolism
Volume87
Issue number8
DOIs
StatePublished - Jan 1 2002

All Science Journal Classification (ASJC) codes

  • Endocrinology, Diabetes and Metabolism
  • Biochemistry
  • Endocrinology
  • Clinical Biochemistry
  • Biochemistry, medical

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    Delmas, P. D., Ensrud, K. E., Adachi, J. D., Harper, K. D., Sarkar, S., Gennari, C., Reginster, J. Y., Pols, H. A. P., Recker, R. R., Harris, S. T., Wu, W., Genant, H. K., Black, D. M., & Eastell, R. (2002). Efficacy of raloxifene on vertebral fracture risk reduction in postmenopausal women with osteoporosis: Four-year results from a randomized clinical trial. Journal of Clinical Endocrinology and Metabolism, 87(8), 3609-3617. https://doi.org/10.1210/jcem.87.8.8750