Effects of raloxifene on bone mineral density, bone metabolism and serum lipids in
healthy Chinese postmenopausal women
Shurong Zheng1, Yiyong Wu 2, Zhonglan Zhang 3, Xin Yang1, Ying Hui2, Yin Zhang3,
Shulin Chen1, Wenhui Deng2, Hui Liu3, Abie Ekangaki4, Jodie Stocks4, Jianli Liu 3,
Kristine Harper5
1
Peking University First Hospital, 2Beijing Hospital, 3General Hospital of PLA, 4Eli Lilly
Australia, 5Eli Lilly and Company
Objective: To determine the effect of raloxifene (RLX), on bone mineral density (BMD),
bone metabolism markers and lipids in healthy Chinese postmenopausal women.
Methods: This was a multicenter, double-blind, placebo-controlled, randomized study
conducted in China with a total of 204 healthy postmenopausal women (mean age 59.5 yr
5.0 sd and weight 62.8 kg 8.7 sd) treated with either RLX 60 mg (n=102) or placebo
(n=102) daily for 12 months. BMD was measured by dual-energy x-ray absorptiometry.
Results: There were no significant differences in baseline characteristics between the two
treatment groups. Compared to 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 to a decrease of 0.1% with placebo (between-group
p<0.001). Corresponding values for total hip BMD were increases of 2.5% for RLX and
1.1% for placebo (between-group p=0.011). The biochemical markers of bone
metabolism, serum osteocalcin and serum C-telopeptide, decreased significantly with
RLX compared to placebo. For serum C-telopeptide, the median decrease was 894.5
pmol/L (24.0%) with RLX compared to a median increase of 603.0 pmol/L (15.8%) with
placebo (between-group p<0.001). The median changes in serum osteocalcin were
decreases of 4.0 ng/ml (27.7%) and 1.5 ng/ml (10.6%) with RLX and placebo,
respectively (between-group p<0.001). Both total cholesterol and low-density lipoprotein
cholesterol decreased significantly with RLX compared to placebo (both between-group
p<0.001). There were no between-group differences for high-density lipoprotein
cholesterol or triglyceride levels. Five patients reported serious adverse events, with
endometrial carcinoma, cardiac neurosis, enlarged uterine fibroids and vascular disorder
for RLX and angina pectoris for placebo (between-group p=0.174). There were no
significant differences between groups for vasodilatation (13 patients with RLX and 8
patients with placebo) or leg cramps (13 patients with RLX and 8 patients with placebo),
and deep venous thrombosis was not reported in either 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 healthy Chinese postmenopausal
women.