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.