¡¾SMID¡¿LW7778
¡¾PMID¡¿
¡¾ISIID¡¿
¡¾Title¡¿Effects of raloxifene hydrochloride on bone mineral density, bone metabolism and serum lipids in Chinese postmenopausal women with osteoporosis: a multi-center, randomized, placebo-controlled clinical trial
¡¾Column¡¿Original Article
¡¾Author 1¡¿LIU Jian-li Áõ½¨Á¢
¡¾Affiliation 1¡¿Department of Obstetrics and Gynaecology, General Hospital of the People¡¯s Liberation Army, Beijing 100853, China
¡¾Author 2¡¿
ZHU Han-min Ö캺Ãñ
¡¾Affiliation 2¡¿
Department of Gerontology, Huadong Hospital, Shanghai 200040, China
¡¾Author 3¡¿
HUANG Qi-ren »Æç÷ÈÊ
¡¾Affiliation 3¡¿
Center for Preventing and Treating Osteoporosis, Sixth People¡¯s Hospital, Shanghai Jiaotong University, Shanghai 200233, China
¡¾Author 4¡¿
ZHANG Zhong-lan ÕÅÖÒÀ¼
¡¾Affiliation 4¡¿
Department of Obstetrics and Gynaecology, General Hospital of the People¡¯s Liberation Army, Beijing 100853, China
¡¾Author 5¡¿
LI Hui-linÀî»ÛÁÖ
¡¾Affiliation 5¡¿
Department of Gerontology, Huadong Hospital, Shanghai 200040, China
¡¾Author 6¡¿
QIN Yue-juan ÇØÔ¾¾ê
¡¾Affiliation 6¡¿
Center for Preventing and Treating Osteoporosis, Sixth People¡¯s Hospital, Shanghai Jiaotong University, Shanghai 200233, China
¡¾Author 7¡¿
ZHANG Ying ÕÅ Ó±
¡¾Affiliation 7¡¿
Department of Obstetrics and Gynaecology, General Hospital of the People¡¯s Liberation Army, Beijing 100853, China
¡¾Author 8¡¿
WEI Dao-lin κµÀÁÖ
¡¾Affiliation 8¡¿
Department of Gerontology, Huadong Hospital, Shanghai 200040, China
¡¾Author 9¡¿
LU Jing-hui ½¾´»Ô
¡¾Affiliation 9¡¿
Center for Preventing and Treating Osteoporosis, Sixth People¡¯s Hospital, Shanghai Jiaotong University, Shanghai 200233, China
¡¾Author 10¡¿
LIU Hui Áõ »Û
¡¾Affiliation 10¡¿
Department of Obstetrics and Gynaecology, General Hospital of the People¡¯s Liberation Army, Beijing 100853, China
¡¾Author 11¡¿
CHEN Xiao-ping ³ÂСƽ
¡¾Affiliation 11¡¿
Department of Gerontology, Huadong Hospital, Shanghai 200040, China
¡¾Author 12¡¿
LIU Yu-juan ÁõÓñ¾ê
¡¾Affiliation 12¡¿
Center for Preventing and Treating Osteoporosis, Sixth People¡¯s Hospital, Shanghai Jiaotong University, Shanghai 200233, China
¡¾Author 13¡¿
Abie Ekangaki
¡¾Affiliation 13¡¿
Eli Lilly and Company, Indianapolis, USA
¡¾Author 14¡¿
ZHENG Yi-man Ö£ÒÔÂþ
¡¾Affiliation 14¡¿
Eli Lilly and Company, Indianapolis, USA
¡¾Author 15¡¿
Adolfo Diez-Perez
¡¾Affiliation 15¡¿
Eli Lilly and Company, Indianapolis, USA
¡¾Author 16¡¿
Kristine Harper
¡¾Affiliation 16¡¿
Eli Lilly and Company, Indianapolis, USA
¡¾Corresponding Author¡¿Liu Jian-li
¡¾Corresponding Address¡¿Department of Obstetrics and Gynaecology, General Hospital of the People¡¯s Liberation Army, Beijing 100853, China
¡¾Corresponding Email¡¿jianliliu301@hotmail.com
¡¾Corresponding Tel¡¿86-10-66936361
¡¾Keywords¡¿raloxifene;bone density;bone metabolism markers;osteoporosis, postmenopausal
¡¾Source¡¿Chinese Medical Journal, 2004, Vol.117 No.7: 1029-1035
¡¾Abstract¡¿Background Raloxifene has been approved for prevention and treatment of postmenopausal osteoporosis in Caucasian women. It also has some positive effects on serum lipids in Caucasians. The objective of this study was to determine the effect of raloxifene hydrochloride on lumbar spine and total hip bone mineral density (BMD), bone metabolism, and serum lipids in Chinese postmenopausal women with osteoporosis.Methods This was a multi-center, randomized, double-blind, placebo-controlled clinical trial in which 204 postmenopausal Chinese women with osteoporosis were assigned to receive raloxifene (60 mg) or placebo treatment daily for 12 months. BMD, serum bone metabolism markers, and serum lipids were measured before and after drug administration. BMD was measured by Dual-Energy X-Ray Absorptiometry (DEXA) and bone metabolism markers were analyzed by one-step enzyme-linked immunosorbent assay. Serum lipids were measured by enzymatic analysis.Results At the end of the 12-month study, lumbar spine BMD increased in both groups with a mean increase of (3.3¡À4.8) % in the raloxifene group and (1.0¡À4.9) % in the placebo group (P<0.001). There was a mean increase in total hip BMD of (1.4¡À4.8) % in the raloxifene group and a mean decrease of (0.9¡À5.0) % in the placebo group (P<0.001). No subject in the raloxifene group had a new vertebral fracture and 5 placebo subjects had new fractures (P>0.05). In the raloxifene group, the median decreases in the biochemical markers of bone metabolism serum osteocalcin and C-telopeptide were 41.7% and 61.5%, respectively. These changes were statistically significant compared with those in the placebo group (10.6% and 35.6%, P<0.001, respectively). Both total cholesterol and low-density lipoprotein cholesterol decreased significantly in the raloxifene group compared with those in the placebo group (P<0.001, respectively) and there was no significant effect of raloxifene on high-density lipoprotein cholesterol and triglycerides compared with placebo. Conclusions Raloxifene 60 mg/d for 12 months significantly increases lumbar spine and total hip BMD, significantly decreases bone turnover, and has favourable effects on serum lipids in Chinese postmenopausal women with osteoporosis.
¡¾Fulltext Url¡¿ http://www.cmj.org/periodical/PaperList.asp?id=LW7778