title: Effects of raloxifene hydrochloride on bone mineral density, bone metabolism and serum lipids in postmenopausal women: a randomized clinical trial in Beijing.
abstract: 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.
authors.affiliation: Department of Obstetrics and Gynaecology, Peking University First Hospital, Beijing 100034, China. cyzh@public.fhnet.cn.net
authors.forename: Shurong
authors.initials: S
authors.lastname: Zheng
authors.forename: Yiyong
authors.initials: Y
authors.lastname: Wu
authors.forename: Zhonglan
authors.initials: Z
authors.lastname: Zhang
authors.forename: Xin
authors.initials: X
authors.lastname: Yang
authors.forename: Ying
authors.initials: Y
authors.lastname: Hui
authors.forename: Ying
authors.initials: Y
authors.lastname: Zhang
authors.forename: Shuling
authors.initials: S
authors.lastname: Chen
authors.forename: Wenhui
authors.initials: W
authors.lastname: Deng
authors.forename: Hui
authors.initials: H
authors.lastname: Liu
authors.forename: Abie
authors.initials: A
authors.lastname: Ekangaki
authors.forename: Jodie
authors.initials: J
authors.lastname: Stocks
authors.forename: Kristine
authors.initials: K
authors.lastname: Harper
authors.forename: Jianli
authors.initials: J
authors.lastname: Liu
mesh_terms: D000368:Aged; D015415:Biomarkers / Q000097:blood; D015519:Bone Density / Q000187:drug effects*; D001842:Bone and Bones / Q000378:metabolism*; D002681:China; D004965:Estrogen Antagonists / Q000494:pharmacology*; D005260:Female; D006801:Humans; D008055:Lipids / Q000097:blood*; D008875:Middle Aged; D017698:Postmenopause / Q000502:physiology*; D020849:Raloxifene Hydrochloride / Q000494:pharmacology*; D020845:Selective Estrogen Receptor Modulators / Q000494:pharmacology*
chemical_list: D015415:Biomarkers; D004965:Estrogen Antagonists; D008055:Lipids; D020845:Selective Estrogen Receptor Modulators; D020849:Raloxifene Hydrochloride