[Effect of raloxifene hydrochloride on bone mineral density, bone metabolism and serum lipids in Chinese postmenopausal women with osteoporosis].
OBJECTIVE
To determine the effect of raloxifene hydrochloride (RLX) on the lumbar spine and total hip bone mineral density (BMD), bone metabolism and serum lipids in Chinese postmenopausal women with osteoporosis.


METHODS
204 Chinese postmenopausal women with osteoporosis from 3 hospitals in Beijing and Shanghai were randomly divided into 2 groups of 102 women: RLX group (RLX of the dosage of 60 mg/day was given for 12 months) and placebo group. In addition, 500 mg of elemental calcium and 200 units of vitamin D were given daily to all women. BMD, serum bone markers and lipids were measured before and after drug administration. The BMD of lumber spine and hip was measured by dual-energy X-ray absorptiometry (DEXA). Serum bone gamma-carboxyglutamic acid-containing protein (BGP) and C-teloppeptide were analyzed by one-step ELISA. Serum lipids were measured by enzymatic method.


RESULTS
By the end of the 12-month study period, the lumbar spine BMD was increased by 3.3% +/- 4.8% in the RLX group and 1.0% +/- 4.9% in the placebo group (P < 0.001); the hip BMD was increased by 1.4% +/- 4.8%in the RLX group and decreased by 0.9% +/- 5.0% in the placebo group (P < 0.01). New vertebral fracture occurred in none of the subjects in the RLX group and in 5 subjects of the placebo group (P = 0.059). The serum BGP and CTX decreased by 41.7% and 61.5% respectively in the RLX group, both significantly more than those in the placebo group (10.6% and 35.6% respectively, both P < 0.001). Both the total cholesterol and low-density lipoprotein cholesterol were significantly lower in the RLX group than in the placebo group (both P < 0.001), however, there were no significant differences in high-density lipoprotein cholesterol and triglycerides between these two groups. One subject in the RLX group and 5 subjects in the placebo group discontinued the study due to adverse events. There were no differences in the number of subjects with hot flushes (3 in the RLX group and 1 in the placebo group) and the number of subjects with leg cramps (9 in the RLX group and 4 in the placebo group). No venous thromboembolic event was reported.


CONCLUSIONS
RLX of the dosage of 60 mg/day for 12 months significantly increases the lumbar spine and total hip bone BMD, significantly decreases bone turnover and has favorable effects on serum lipids in Chinese postmenopausal women with osteoporosis.
Liu
Jian-li
JL
Department of Obstetrics and Gynecology, General Hospital of the People's Liberation Army, Beijing 100853, China.
Zhu
Han-min
HM
Huang
Qi-ren
QR
Zhang
Zhong-lan
ZL
Li
Hui-lin
HL
Qin
Yue-juan
YJ
Zhang
Ying
Y
Wei
Dao-lin
DL
Lu
Jing-hui
JH
Liu
Hui
H
Chen
Xiao-ping
XP
Liu
Yu-juan
YJ
Ekangaki
Abie
A
Zheng
Yi-man
YM
Diez-Perez
Adolfo
A
Harpe
Kristine
K
D015055:1-Carboxyglutamic Acid / Q000097:blood; D015502:Absorptiometry, Photon; D000368:Aged; D015519:Bone Density / Q000187:drug effects*; D003094:Collagen / Q000097:blood; D024042:Collagen Type I; D004311:Double-Blind Method; D004797:Enzyme-Linked Immunosorbent Assay; D004965:Estrogen Antagonists / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008055:Lipids / Q000097:blood; D008159:Lumbar Vertebrae / Q000187:drug effects / Q000378:metabolism; D008875:Middle Aged; D015663:Osteoporosis, Postmenopausal / Q000188:drug therapy* / Q000378:metabolism; D010384:Pelvic Bones / Q000187:drug effects / Q000378:metabolism; D010455:Peptides / Q000097:blood; D020849:Raloxifene Hydrochloride / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
D024042:Collagen Type I; D004965:Estrogen Antagonists; D008055:Lipids; D010455:Peptides; C052929:collagen type I trimeric cross-linked peptide; D020849:Raloxifene Hydrochloride; D015055:1-Carboxyglutamic Acid; D003094:Collagen