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Efficacy of Raloxifene on Vertebral Fracture Risk Reduction in Postmenopausal Women with Osteoporosis: Four-Year Results from a Randomized Clinical Trial

University of Claude Bernard of Lyon (P.D.D.), Hôpital Edouard Herriot, Service de Rhumatologie et de Pathologie Osseuse, Lyon 69437, France; Department of Medicine (K.E.E.), Minneapolis VA Medical Center, Minneapolis, Minnesota 55417; St. Joseph’s Hospital (J.D.A.), McMaster University, Hamilton, Ontario, L8N 1Y2 Canada; Lilly Research Laboratories (K.D.H., S.S., W.W.), Eli Lilly and Company, Indianapolis, Indiana 46285; Institute of Internal Medicine and Medical Pathology (C.G.), University of Siena, 53100 Siena, Italy; Bone/Cartilage Metabolism Unit (J.-Y.R.), Centre Hôpital Universitaire Centre-Ville, Liege 04020, Belgium; Department of Internal Medicine (H.A.P.P.), Erasmus University Medical School, Rotterdam DR 3000, The Netherlands; Osteoporosis Research Center (R.R.R.), Creighton University, Omaha, Nebraska 68131; Departments of Medicine (S.T.H.), Epidemiology and Biostatistics (D.M.B.), and Musculoskeletal Radiology (H.K.G.), University of California at San Francisco, San Francisco, California 94117; and Northern General Hospital (R.E.), Clinical Science Center, University of Sheffield, Sheffield, Yorkshire S5 7AU United Kingdom

Address all correspondence and requests for reprints to: Pierre D. Delmas, M.D., Ph.D., University Claude Bernard of Lyon, Hôpital Edouard Herriot, Pavillon F, Lyon, Cedex 03 69437, France. E-mail: . delmas{at}lyon151.inserm.fr

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.

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