1.Effects of raloxifene hydrochloride on bone mineral density, bone metabolism and serum lipids in postmenopausal women: a randomized clinical trial in Beijing.
Shurong ZHENG ; Yiyong WU ; Zhonglan ZHANG ; Xin YANG ; Ying HUI ; Ying ZHANG ; Shuling CHEN ; Wenhui DENG ; Hui LIU ; Abie EKANGAKI ; Jodie STOCKS ; Kristine HARPER ; Jianli LIU
Chinese Medical Journal 2003;116(8):1127-1133
OBJECTIVETo determine the effects of raloxifene hydrochloride (RLX) on bone mineral density (BMD), bone metabolism markers and serum lipids in healthy postmenopausal women in Beijing.
METHODSA 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.
RESULTSCompared 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).
CONCLUSIONSThis 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.
Aged ; Biomarkers ; blood ; Bone Density ; drug effects ; Bone and Bones ; metabolism ; China ; Estrogen Antagonists ; pharmacology ; Female ; Humans ; Lipids ; blood ; Middle Aged ; Postmenopause ; physiology ; Raloxifene Hydrochloride ; pharmacology ; Selective Estrogen Receptor Modulators ; pharmacology
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