Treatment of postmenopausal women with osteoporosis or low bone density with raloxifene

Raloxifene, a selective estrogen receptor modulator (SERM), has been shown to improved bone mineral density (BMD) and serum lipid profiles in healthy postmenopausal women. The objective of this study was to examine the effect s of raloxifene on BMD, biochemical markers of bone metabolism and serum li pids in postmenopausal women with low bone density or osteoporosis. This Ph ase II, multicenter, 24-month, double-masked study assessed the efficacy an d safety of raloxifene in 129 postmenopausal women (mean age +/- SD: 60.2 /- 6.7 years) with osteoporosis or low bone density (baseline mean lumbar s pine BMD T-score: -2.8). Women were randomly assigned to one of three treat ment groups: placebo, 60 mg/day raloxifene-HCl (RLX 60) or 150 mg/day ralox ifene-HCl (RLX 150) and concomitantly received 1000 mg/day calcium and 300 U/day vitamin D-3. At 24 months, BMD was significantly increased in the lum bar spine (+3.2%), femoral neck (+2.1%), trochanter (+2.7%) and total hip ( +1.6%) in the RLX 60 group compared with the placebo group (p<0.05). The RL X 150 group had increases in BMD similar to those observed with RLX 60. A. greater percentage of raloxifene-treated patients, compared with those rece iving placebo, had increased BMD (p<0.05). Serum bone-specific alkaline pho sphatase activity, serum osteocalcin, and urinary type I collagen:creatinin e ratio were significantly decreased in the RLX-treated groups, compared wi th the placebo group (p<0.01). RLX 60 treatment significantly decreased ser um levels of triglycerides, and total- and LDL-cholesterol levels (p<0.01). The rates of patient discontinuation and adverse events were not significa ntly different among groups. In this study, raloxifene increased bone densi ty, decreased bone turnover, and improved the serum lipid profile with mini mal adverse events, and may be a safe and effective treatment for postmenop ausal women with osteoporosis or low bone density.