Effects of raloxifene hydrochloride on bone mineral density, bone metabolism and serum lipids in postmenopausal women: a randomized clinical trial in Beijing.

Objective To determine the effects of raloxifene hydrochloride ( RLX) on bone mineral density (BMD), bone metabolism markers and serum lipids in healthy postmenopausal women in Beijing. Methods A multicenter, randomized, double-blind, placebo-controlled study was conducted in a total of 204 healthy postmenopausal women (age 59. 5 ′5. 0 years and weight 62. 8 ′8.7 kg) treated with either RLX 60 mg (n = 102) or placebo (n =102) daily for 12 months. BMD, serum lipids, and bone markers were measured before and after drug administration. Results Compared with placebo, RLX produced a significant increase in both total lumbar spine and total hip BMD. For the lumbar spine, percentage increase in total BMD was 2. 3% with RLX compared with a decrease of 0. 1% with placebo (P<0. 001). Corresponding values for total hip BMD were a 2. 5% increase for RLX and a 1. 1% increase for placebo (P = 0. 011). For biochemical markers of bone metabolism, serum osteocalcin and C-telopeptide, percentage decreases were 27. 65% and 24. 02% in RLX-treated subjects. Corresponding values in placebo were a 10. 64% decrease and a 15. 75% increase (RLX compared with placebo, both P < 0. 001). For total cholesterol and low-density lipoprotein cholesterol levels, percentage decreases were 6. 44% and 34. 58% in the RLX-treated group. Corresponding values in placebo-treated patients were a 1.44% increase and a 19. 07% decrease (RLX compared with placebo, both P<0.001). No differences were found for high-density lipoprotein cholesterol or triglyceride levels between the two groups. Only 5 subjects discontinued early owing to an adverse event (3 in the RLX group and 2 in the placebo group). Conclusions This study confirms that RLX exerts positive effects on the skeleton, increasing BMD and decreasing biochemical markers of bone metabolism, and has a positive effect on the overall serum lipid profile in postmenopausal women in China.