Raloxifene reduces fractures in postmenopausal women with osteoporosis.

UNLABELLED: Recently, selective estrogen receptor modulators have been developed for the management of osteoporosis based on antiosteoclastic properties similar to that of estrogens but with a safety profile including potential benefits on the breast, heart, and cognitive function. Raloxifene, the first selective estrogen receptor modulator to be marketed for the treatment of osteoporosis has shown reduction in spinal fracture risk in patients with low bone mineral density with (48%) or without (35%) prevalent vertebral fracture. Raloxifene also reduces nonvertebral fractures in high risk patients (47%). The decrease in Type I procollagen N-terminal propeptide at 1 year accounts for 28% of the total reduction in vertebral fracture risk. Raloxifene reduced the risk of estrogen receptor-positive invasive breast cancer by 84%. Among subjects with increased cardiovascular risk at baseline, those assigned to raloxifene had a 40% decrease in the risk of cardiovascular events compared with placebo. The definite anti-fracture efficacy of raloxifene at the spine, its plausible effect on non-spine fracture in high-risk patients and its beneficial effect on breast and heart make this compound an interesting approach for women presenting with osteoporosis. LEVEL OF EVIDENCE: Therapeutic study, level II (lesser quality randomized controlled trial [eg, < 80% followup, no blinding, or improper randomization]). See the Guidelines for Authors for a complete description of the levels of evidence.

RCT Entities:   Population Interventions Outcomes