The safety and efficacy of
raloxifene, a
selective estrogen receptor modulator (
SERM), has been studied extensively in large, global clinical trials. However, the effect of
raloxifene on bone mineral density (BMD) and on
biochemical markers of bone turnover in Japanese postmenopausal women with
osteoporosis has not been rigorously evaluated. This study was designed to assess the safety and efficacy of
raloxifene in Japanese postmenopausal women with
osteoporosis following 1 year of
therapy. Participants in this multicenter trial were randomly assigned to receive placebo,
raloxifene 60 mg/day (RLX60), or
raloxifene 120 mg/day (RLX120). Lumbar spine BMD was measured at baseline, 24, 40, and 52 weeks, and
biochemical markers of bone turnover were assessed at baseline, 12, 24, and 52 weeks. Serum
lipids were assessed at baseline, 12, 24, 40, and 52 weeks, and breast examinations and transvaginal ultrasound of the endometrium were performed at enrollment and 52 weeks. Compared with baseline, women taking RLX60 had significant increases in lumbar spine (L2-L4) BMD at 24 weeks (+3.3%, p<0.001) through 52 weeks (+3.5%, p<0.001) of
therapy, and similar results were observed in the RLX120 group. Markers of bone turnover and total
cholesterol and
LDL-C were significantly reduced, and no significant treatment-group difference was observed for patients reporting at least one adverse event following randomization. In addition, there were no reported venous thromboembolic events (VTE) in any treatment group. The results of this study demonstrate that
raloxifene is associated with early increases in lumbar spine BMD, has favorable effects on
biochemical markers of bone turnover and
lipid profile, and is well tolerated in postmenopausal Japanese women.