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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.
Chin Med J (Engl). 2004 Jul; 117(7):1029-35.CM

Abstract

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 +/- 4.8)% in the raloxifene group and (1.0 +/- 4.9)% in the placebo group (P < 0.001). There was a mean increase in total hip BMD of (1.4 +/- 4.8)% in the raloxifene group and a mean decrease of (0.9 +/- 5.0)% 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.

Authors+Show Affiliations

Department of Obstetrics and Gynaecology, General Hospital of the People's Liberation Army, Beijing 100853, China. jianliliu301@hotmail.comNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

15265377

Citation

Liu, Jian-li, et al. "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." Chinese Medical Journal, vol. 117, no. 7, 2004, pp. 1029-35.
Liu JL, Zhu HM, Huang QR, et al. 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. Chin Med J (Engl). 2004;117(7):1029-35.
Liu, J. L., Zhu, H. M., Huang, Q. R., Zhang, Z. L., Li, H. L., Qin, Y. J., Zhang, Y., Wei, D. L., Lu, J. H., Liu, H., Chen, X. P., Liu, Y. J., Ekangaki, A., Zheng, Y. M., Diez-Perez, A., & Harper, K. (2004). 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. Chinese Medical Journal, 117(7), 1029-35.
Liu JL, et al. 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. Chin Med J (Engl). 2004;117(7):1029-35. PubMed PMID: 15265377.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Liu,Jian-li, AU - Zhu,Han-min, AU - Huang,Qi-ren, AU - Zhang,Zhong-lan, AU - Li,Hui-lin, AU - Qin,Yue-juan, AU - Zhang,Ying, AU - Wei,Dao-lin, AU - Lu,Jing-hui, AU - Liu,Hui, AU - Chen,Xiao-ping, AU - Liu,Yu-juan, AU - Ekangaki,Abie, AU - Zheng,Yi-man, AU - Diez-Perez,Adolfo, AU - Harper,Kristine, PY - 2004/7/22/pubmed PY - 2004/10/29/medline PY - 2004/7/22/entrez SP - 1029 EP - 35 JF - Chinese medical journal JO - Chin Med J (Engl) VL - 117 IS - 7 N2 - 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 +/- 4.8)% in the raloxifene group and (1.0 +/- 4.9)% in the placebo group (P < 0.001). There was a mean increase in total hip BMD of (1.4 +/- 4.8)% in the raloxifene group and a mean decrease of (0.9 +/- 5.0)% 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. SN - 0366-6999 UR - https://www.unboundmedicine.com/medline/citation/15265377/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_ L2 - https://www.diseaseinfosearch.org/result/9059 DB - PRIME DP - Unbound Medicine ER -