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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. JAMA. 1999;282(7):637–645. doi:https://doi.org/10.1001/jama.282.7.637
Author Affiliations: Division of Research, Kaiser Permanente, Oakland, Calif (Dr Ettinger) and Departments of Epidemiology and Biostatistics (Drs Black and Cummings), Radiology (Dr Genant), and Medicine (Dr Cummings), University of California, San Francisco; Eli Lilly and Co, Indianapolis, Ind (Drs Mitlak, Knickerbocker, Nickelsen, Krueger, Cohen, and Eckert); Center for Clinical and Basic Research, Ballerup, Denmark (Dr Christiansen); INSERM, Lyon, France (Dr Delmas); Instituto de Investigaciones Metabólicas, Buenos Aires, Argentina (Dr Zanchetta); Center for Clinical Osteoporosis Research CECOR AS, Haugesund, Norway (Dr Stakkestad); Department of Diagnostic Radiology, Cristian-Albrechts–Universität Kiel, Germany (Dr Glüer); Veterans Affairs Medical Center, Minneapolis, Minn (Dr Ensrud); Washington University, St Louis, Mo (Dr Avioli); and Vrije Universiteit, Amsterdam, the Netherlands (Dr Lips).
Context Raloxifene hydrochloride, a selective estrogen receptor modulator, prevents
bone loss in postmenopausal women, but whether it reduces fracture risk in
these women is not known.
Objective To determine the effect of raloxifene therapy on risk of vertebral and
Design The Multiple Outcomes of Raloxifene Evaluation (MORE) study, a multicenter,
randomized, blinded, placebo-controlled trial.
Setting and Participants A total of 7705 women aged 31 to 80 years in 25 countries who had been
postmenopausal for at least 2 years and who met World Health Organization
criteria for having osteoporosis. The study began in 1994 and had up to 36
months of follow-up for primary efficacy measurements and nonserious adverse
events and up to 40 months of follow-up for serious adverse events.
Interventions Participants were randomized to 60 mg/d or 120 mg/d of raloxifene or
to identically appearing placebo pills; in addition, all women received supplemental
calcium and cholecalciferol.
Main Outcome Measures Incident vertebral fracture was determined radiographically at baseline
and at scheduled 24- and 36-month visits. Nonvertebral fracture was ascertained
by interview at 6-month-interim visits. Bone mineral density was determined
annually by dual-energy x-ray absorptiometry.
Results At 36 months of the evaluable radiographs in 6828 women, 503 (7.4%)
had at least 1 new vertebral fracture, including 10.1% of women receiving
placebo, 6.6% of those receiving 60 mg/d of raloxifene, and 5.4% of those
receiving 120 mg/d of raloxifene. Risk of vertebral fracture was reduced in
both study groups receiving raloxifene (for 60-mg/d group: relative risk [RR],
0.7; 95% confidence interval [CI], 0.5-0.8; for 120-mg/d group: RR, 0.5; 95%
CI, 0.4-0.7). Frequency of vertebral fracture was reduced both in women who
did and did not have prevalent fracture. Risk of nonvertebral fracture for
raloxifene vs placebo did not differ significantly (RR, 0.9; 95% CI, 0.8-1.1
for both raloxifene groups combined). Compared with placebo, raloxifene increased
bone mineral density in the femoral neck by 2.1% (60 mg) and 2.4% (120 mg)
and in the spine by 2.6% (60 mg) and 2.7% (120 mg) P<0.001
for all comparisons). Women receiving raloxifene had increased risk of venous
thromboembolus vs placebo (RR, 3.1; 95% CI, 1.5-6.2). Raloxifene did not cause
vaginal bleeding or breast pain and was associated with a lower incidence
of breast cancer.
Conclusions In postmenopausal women with osteoporosis, raloxifene increases bone
mineral density in the spine and femoral neck and reduces risk of vertebral
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