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QUESTION: In postmenopausal women with osteoporosis, does raloxifene reduce the rate of vertebral and non-vertebral fractures?
Randomised (allocation concealed*), blinded (patients, clinicians, and outcome assessors),* placebo controlled trial.
180 clinical centres in 25 countries.
7705 postmenopausal women (mean age 67 y, 96% white) with osteoporosis. Exclusion criteria included other bone diseases, postmenopausal symptoms, abnormal uterine bleeding, history of breast or endometrial cancer or thromboembolic disorders, other cancers, treated endocrine disorders except type 2 diabetes or hypothyroidism, renal lithiasis, abnormal hepatic or renal function, untreated malabsorption, and consumption of >4 drinks of alcohol/d. Follow up was 89%.
Women received calcium, 500 mg/d, and cholecalciferol, 400 to 600 IU/d, and were allocated …