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[A randomised clinical trial to study the effects of raloxifene hydrochloride on bone mineral density, biochemical markers of bone metabolism and serum lipids in postmenopausal women].
Zhonghua Fu Chan Ke Za Zhi 2003; 38(4):226-9ZF

Abstract

OBJECTIVE

To determine the effect of raloxifene hydrochloride (RLX) on bone mineral density (BMD), biochemical markers of bone metabolism and lipid metabolism in Chinese postmenopausal women.

METHODS

This was a multicenter, randomized, double blind placebo controlled study in China with a total of 204 postmenopausal women [mean age (60 +/- 5) years (x +/- s) and weight (63 +/- 9) kg (x +/- s)] treated with either RLX 60 mg (n = 102) or placebo (n = 102) daily for 12 months. BMD, serum lipid and bone markers were determined before and after drug administration.

RESULTS

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 2.30% with RLX compared to a decrease of 0.08% with placebo (P < 0.001). Corresponding values for total hip BMD were 2.46% increase for RLX and 1.07% for placebo (P < 0.05). For biochemical markers of bone metabolism, serum osteocalcin and C-telopeptide, percentage decrease were 27.6% and 24.0% in raloxifene-treated subjects. Corresponding values in placebo were 10.6% decrease and 15.8% increase (RLX compared to placebo, both P < 0.001). For total cholesterol and low-density lipoprotein cholesterol, percentage decrease were 6.4% and 34.6% in the raloxifene-treated group. Corresponding values in placebo were 1.4% increase and 19.1% decrease (RLX compared to 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 due 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 decreased total cholesterol and low-density lipoprotein cholesterol in postmenopausal women in China.

Authors+Show Affiliations

Department of Obstetrics and Gynecology, First Hospital, Peking University Beijing 100034, China.No 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
Comparative Study
English Abstract
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

chi

PubMed ID

12885371

Citation

Zheng, Shu-rong, et al. "[A Randomised Clinical Trial to Study the Effects of Raloxifene Hydrochloride On Bone Mineral Density, Biochemical Markers of Bone Metabolism and Serum Lipids in Postmenopausal Women]." Zhonghua Fu Chan Ke Za Zhi, vol. 38, no. 4, 2003, pp. 226-9.
Zheng SR, Wu YY, Zhang ZL, et al. [A randomised clinical trial to study the effects of raloxifene hydrochloride on bone mineral density, biochemical markers of bone metabolism and serum lipids in postmenopausal women]. Zhonghua Fu Chan Ke Za Zhi. 2003;38(4):226-9.
Zheng, S. R., Wu, Y. Y., Zhang, Z. L., Yang, X., Hui, Y., Zhang, Y., ... Liu, J. L. (2003). [A randomised clinical trial to study the effects of raloxifene hydrochloride on bone mineral density, biochemical markers of bone metabolism and serum lipids in postmenopausal women]. Zhonghua Fu Chan Ke Za Zhi, 38(4), pp. 226-9.
Zheng SR, et al. [A Randomised Clinical Trial to Study the Effects of Raloxifene Hydrochloride On Bone Mineral Density, Biochemical Markers of Bone Metabolism and Serum Lipids in Postmenopausal Women]. Zhonghua Fu Chan Ke Za Zhi. 2003;38(4):226-9. PubMed PMID: 12885371.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - [A randomised clinical trial to study the effects of raloxifene hydrochloride on bone mineral density, biochemical markers of bone metabolism and serum lipids in postmenopausal women]. AU - Zheng,Shu-rong, AU - Wu,Yi-yong, AU - Zhang,Zhong-lan, AU - Yang,Xin, AU - Hui,Ying, AU - Zhang,Ying, AU - Chen,Shu-ling, AU - Den,Wen-hui, AU - Liu,Hui, AU - Ekangaki,Abie, AU - Stocks,Jodie, AU - Harper,Kristine, AU - Liu,Jian-li, PY - 2003/7/30/pubmed PY - 2004/12/16/medline PY - 2003/7/30/entrez SP - 226 EP - 9 JF - Zhonghua fu chan ke za zhi JO - Zhonghua Fu Chan Ke Za Zhi VL - 38 IS - 4 N2 - OBJECTIVE: To determine the effect of raloxifene hydrochloride (RLX) on bone mineral density (BMD), biochemical markers of bone metabolism and lipid metabolism in Chinese postmenopausal women. METHODS: This was a multicenter, randomized, double blind placebo controlled study in China with a total of 204 postmenopausal women [mean age (60 +/- 5) years (x +/- s) and weight (63 +/- 9) kg (x +/- s)] treated with either RLX 60 mg (n = 102) or placebo (n = 102) daily for 12 months. BMD, serum lipid and bone markers were determined before and after drug administration. RESULTS: 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 2.30% with RLX compared to a decrease of 0.08% with placebo (P < 0.001). Corresponding values for total hip BMD were 2.46% increase for RLX and 1.07% for placebo (P < 0.05). For biochemical markers of bone metabolism, serum osteocalcin and C-telopeptide, percentage decrease were 27.6% and 24.0% in raloxifene-treated subjects. Corresponding values in placebo were 10.6% decrease and 15.8% increase (RLX compared to placebo, both P < 0.001). For total cholesterol and low-density lipoprotein cholesterol, percentage decrease were 6.4% and 34.6% in the raloxifene-treated group. Corresponding values in placebo were 1.4% increase and 19.1% decrease (RLX compared to 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 due 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 decreased total cholesterol and low-density lipoprotein cholesterol in postmenopausal women in China. SN - 0529-567X UR - https://www.unboundmedicine.com/medline/citation/12885371/[A_randomised_clinical_trial_to_study_the_effects_of_raloxifene_hydrochloride_on_bone_mineral_density_biochemical_markers_of_bone_metabolism_and_serum_lipids_in_postmenopausal_women]_ L2 - https://medlineplus.gov/bonedensity.html DB - PRIME DP - Unbound Medicine ER -