Author/Editor		Delmas, Pierre D; Ensrud, Kristine E; Adachi, Jonathan D; Harper, Kristine D; Sarkar, Somnath; Gennari, Carlo; Reginster, Jean-Yves; Pols, Huibert AP; Recker, Robert R; Kocijančič, Andreja
Title		Efficacy of raloxifene on vertebral fracture risk reduction in postmenopausal women with osteoporosis: four-years results from randomized clinical trial
Type		članek
Source		J Clin Endocrinol Metab
Vol. and No.		Letnik 87, št. 8
Publication year		2002
Volume		str. 3609-17
Language		eng
Abstract		The Multiple Outcomes of Raloaifene Evaluation trial etudied 7705 postmenopausal women with osteoporoais randomized to placebo, or ralogifene 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 analyais 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 riske (RR) for one or more new vertebral fractures were 0.64 [95% confidence interval (CI) 0.53, 0.76] with ralogifene 60 mg/d and 0.57 (95% CI 0.48, 0.69) with ralosifene 120 mg/d. In yr 4 alone, ralogifene 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 aignificantly 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.
Descriptors		OSTEOPOROSIS, POSTMENOPAUSAL SPINAL FRACTURES ESTROGEN ANTAGONISTS BONE DENSITY MIDDLE AGE AGED TREATMENT OUTCOME RISK FACTORS POSTMENOPAUSE INCIDENCE FOLLOW-UP STUDIES