IR@PKUHSC  > 北京大学第一临床医学院  > 内分泌内科
学科主题临床医学
A randomized, multicenter controlled trial to compare the efficacy of recombinant human parathyroid hormone (1-34) with elcatonin in postmenopausal women with osteoporosis in China
Zhang Xiu-zhen1; Wang Bo1; Yang Jun1; Xuan Miao1; Song Li-ge1; Li Hong1; Guo Xiao-hui2; Lue Xiao-feng3; Xue Qing-yun4; Yang Gang-yi5; Ji Qiu-he6; Shen Jie7; Liu Zhi-min8; Li Cheng-jiang9; Wu Tian-feng10; Tong Xiao-cui10; Jia Yuan10
关键词Recombinant Human Parathyroid Hormone Elcatonin Osteoporosis Bone Mineral Density
刊名CHINESE MEDICAL JOURNAL
2009-12-20
DOI10.3760/cma.j.issn.0366-6999.2009.24.003
122期:24页:2933-2938
收录类别SCI
文章类型Article
WOS标题词Science & Technology
类目[WOS]Medicine, General & Internal
研究领域[WOS]General & Internal Medicine
关键词[WOS]BONE-MINERAL DENSITY ; ANABOLIC ACTIONS ; VERTEBRAL FRACTURES ; SALMON-CALCITONIN ; TERIPARATIDE ; GROWTH ; MEN ; DIFFERENTIATION ; PROLIFERATION ; ALENDRONATE
英文摘要

Background Recombinant human parathyroid hormone (1-34) (rhPTH (1-34)) given by injection is anew seventh class drug of biological products, which is prepared by adopting gene recombination technique. rhPTH (1-34) is mainly used to treat osteoporosis, especially for postmenopausal women. This study compared the clinical efficacy and safety of rhPTH (1-34) with elcatonin for treating postmenopausal women with osteoporosis in 11 urban areas of China.

Methods Two hundred and five women with osteoporosis were enrolled in a 6-month, multicenter, randomized, controlled study. They were randomized to receive either rhPTH (1-34) 20 mu g (200 U) daily or elcatonin 20 U weekly. Lumbar spine (L1-4) and femoral neck bone mineral density (BMD), as well as biochemical markers of bone turnover were measured. Adverse events were recorded.

Results rhPTH (1-34) increased lumbar BMD significantly more than did. elcatonin at 3 months and 6 months (2.38% vs 0.59%, P<0.05; 5.51% vs 1.55%, P<0.01), but there were no significant increases of BMD in these two groups at femoral neck. There were larger mean increases in bone markers in the rhPTH (1-34) group than in the elcatonin group at 3 months and 6 months (serum bone-specific alkaline phosphatase (BSAP) 36.79% vs 0.31%; 92.42% vs -0.17%; urinary N-telopeptide/creatinine (NTX/Cr) 48.91% vs -5.32%; 68.82% vs -10.86%). Both treatments were well tolerated and there were no significant differences detected between the two groups in the proportion of any adverse events and any serious adverse events (67.0% vs 59.0%; 0 vs 0).

Conclusions rhPTH (1-34) has more positive effects on bone formation, as shown by the larger increments of lumbar BMD and bone formation markers, than elcatonin, with only mild adverse events and no significant change in the liver, kidney or hematological indices. Chin Med J 2009;122(24):2933-2938

语种英语
WOS记录号WOS:000273688700003
Citation statistics
Cited Times:3[WOS]   [WOS Record]     [Related Records in WOS]
文献类型期刊论文
条目标识符http://ir.bjmu.edu.cn/handle/400002259/55815
Collection北京大学第一临床医学院_内分泌内科
作者单位1.Tongji Univ, Dept Endocrinol, Tongji Hosp, Shanghai 200065, Peoples R China
2.Peking Univ, Dept Endocrinol, Hosp 1, Beijing 100034, Peoples R China
3.Gen Hosp Chinese Peoples Liberat Army Beijing Mil, Dept Endocrinol, Beijing 100700, Peoples R China
4.Beijing Hosp, Dept Endocrinol, Beijing 100730, Peoples R China
5.Chongqing Med Univ, Affiliated Hosp 2, Dept Endocrinol, Chongqing 400010, Peoples R China
6.Fourth Mil Med Univ, Dept Endocrinol, Xijing Hosp, Xian 710032, Shaanxi, Peoples R China
7.Nanfang Med Univ, Dept Endocrinol, Nanfang Hosp, Guangzhou 510515, Guangdong, Peoples R China
8.Second Mil Med Univ, Dept Endocrinol, Changzheng Hosp, Shanghai 200003, Peoples R China
9.Zhejiang Univ, Dept Endocrinol, Affiliated Hosp 1, Hangzhou 310003, Zhejiang, Peoples R China
10.Zhejiang Hosp, Dept Endocrinol, Hangzhou 310013, Zhejiang, Peoples R China
Recommended Citation
GB/T 7714
Zhang Xiu-zhen,Wang Bo,Yang Jun,et al. A randomized, multicenter controlled trial to compare the efficacy of recombinant human parathyroid hormone (1-34) with elcatonin in postmenopausal women with osteoporosis in China[J]. CHINESE MEDICAL JOURNAL,2009,122(24):2933-2938.
APA Zhang Xiu-zhen.,Wang Bo.,Yang Jun.,Xuan Miao.,Song Li-ge.,...&Jia Yuan.(2009).A randomized, multicenter controlled trial to compare the efficacy of recombinant human parathyroid hormone (1-34) with elcatonin in postmenopausal women with osteoporosis in China.CHINESE MEDICAL JOURNAL,122(24),2933-2938.
MLA Zhang Xiu-zhen,et al."A randomized, multicenter controlled trial to compare the efficacy of recombinant human parathyroid hormone (1-34) with elcatonin in postmenopausal women with osteoporosis in China".CHINESE MEDICAL JOURNAL 122.24(2009):2933-2938.
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