Author/Editor		Ettinger, Bruce; Black, Dennis M; Miltak, Bruce H; Knickerbocker, Ronald K; Nickelsen, Thomas; Genant, Harry K; Christiansen, Claus; Delmas, Pierre D; Zanchetta, Jose R; Kocijančič, A; et al, ;
Title		Reduction of vertebral fracture risk in postmenopausal women with osteoporosis treated with raloxifene
Type		članek
Source		Jama
Vol. and No.		Letnik 282, št. 7
Publication year		1999
Volume		str. 637-45
Language		eng
Abstract		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 nonvertebral fractures. 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). (Abstract tuncated at 2000 characters)
Descriptors		SPINAL FRACTURES OSTEOPOROSIS, POSTMENOPAUSAL FRACTURES, SPONTANEOUS THIOPHENES RECEPTORS, ESTROGEN MULTICENTER STUDIES RANDOMIZED CONTROLLED TRIALS CALCIUM CHOLECALCIFEROL