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Alendronate sodium/vitamin D-3 combination tablet versus calcitriol for osteoporosis in Chinese postmenopausal women: a 6-month, randomized, open-label, active-comparator-controlled study with a 6-month extension

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收录情况： ◇ SCIE

作者：
Zhang, Z. L.[1,*1] * ; Liao, E. Y.[2] ; Xia, W. B.[3] ; Lin, H.[4] ; Cheng, Q.[5] ; Wang, L.[6] ; Hao, Y. Q.[7] ; Chen, D. C.[8] ; Tang, H.[9] ; De Peng, Y.[10] ; You, L.[10] ; He, L.[11] ; Hu, Z. H.[11,12] ; Song, C. L.[13] ; Wei, F.[14] ; Wang, J.[14] ; Zhang, L.[14] ; Santora, A. C.[15] ;
单位： [1]Shanghai Jiao Tong Univ, Peoples Hosp 6, Metab Bone Dis & Genet Res Unit, Dept Osteoporosis & Bone Dis, Shanghai 200233, Peoples R China [2]Cent S Univ, Xiangya Hosp 2, Changsha, Hunan, Peoples R China [3]Beijing Union Med Coll Hosp, Beijing, Peoples R China [4]Nanjing Drum Tower Hosp, Nanjing, Jiangsu, Peoples R China [5]Fudan Univ, Huadong Hosp, Shanghai 200433, Peoples R China [6]Tianjin Hosp, Tianjin, Peoples R China [7]Shanghai Ninth Peoples Hosp, Shanghai, Peoples R China [8]Sichuan Univ, West China Sch Med, West China Hosp, Chengdu 610064, Peoples R China [9]Capital Med Univ, Beijing Friendship Hosp, Beijing, Peoples R China [10]Shanghai First Peoples Hosp, Shanghai, Peoples R China [11]Beijing Jishuitan Hosp, Beijing, Peoples R China [12]Peking Univ, Peoples Hosp, Beijing 100871, Peoples R China [13]Peking Univ, Third Hosp, Beijing 100871, Peoples R China [14]Merck Sharp & Dohme China, Global Med Affairs, Shanghai, Peoples R China [15]Merck Res Labs, Rahway, NJ USA
出处：
DOI： 10.1007/s00198-015-3141-y
ISSN：

关键词： Alendronate Calcitriol China Postmenopausal osteoporosis Vitamin D

摘要：
This study compares efficacy of ALN/D5600 versus that of calcitriol in osteoporotic Chinese postmenopausal women. ALN/D5600 produced greater bone mineral density (BMD) increases, greater bone turnover marker decreases, and less vitamin D insufficiency. This study provided detailed clinical information regarding ALN/D5600 treatment versus calcitriol 0.25 mu g/day. The study did not evaluate fracture risk. Introduction The aim of this study is to investigate efficacy of alendronate 70 mg/vitamin D-3 5600 IU combination tablets (ALN/D5600) versus calcitriol in osteoporotic Chinese postmenopausal women. Methods This study is a 6-month, randomized, open-label, active-comparator study with 6-month extension (clinicaltrials.gov number NCT01350934) in postmenopausal women aged > 55 years with osteoporosis (low bone mineral density (BMD) with/without prior fragility fracture). Patients were randomized to ALN/D5600 once weekly or calcitriol 0.25 mu g daily. The primary efficacy end point of the base study was percent change from baseline in lumbar spine BMD (month 6). Hypercalcemia and hypercalciuria were safety events of special interest. Results A total of 219 patients (ALN/D5600 n=111, calcitriol n=108) were randomized. Baseline characteristics were similar, 30.3 % baseline 25-hydroxyvitamin D (25(OH)D) <= 15 ng/mL. At months 6 and 12, changes in lumbar spine BMD from baseline were 3.5 versus 1.6 % and 5.2 versus 2.3 % for ALN/D5600 versus calcitriol (between-group differences p < 0.001), respectively. Between-group differences for ALN/D5600 versus calcitriol were significant (p < 0.001) at months 6 and 12 for change from baseline in procollagen type 1 N-terminal propeptide (-59.1 versus -16.8 %, -68.1 versus -17.0 %) and serum C-telopeptides (-79.2 versus -27.2 %, -76.2 versus -24.2 %). Drug-related adverse events (AEs) and discontinuations due to drug-related AEs occurred in 15 (14.0 %) versus 8 (7.4 %) patients and 3 (2.8 %) versus 0 patients in the ALN/D5600 and calcitriol group, respectively. Hypercalciuria 12-month incidence (24-h urine Ca > 300 mg) was 8.4 (ALN/D5600) versus 13.9 % (calcitriol) (p > 0.05). One patient (calcitriol) had hypercalcemia. Conclusions ALN/D5600 produced greater increases in lumbar spine BMD and greater decreases in bone turnover markers versus calcitriol in osteoporotic Chinese women. It is not known whether the greater increase in BMD results in fewer fractures. ALN/D5600 was generally well tolerated in Chinese patients.

基金：
MSD China Holding Co., Ltd., China; Merck & Co., Inc., Whitehouse Station, NJ, USAMerck & Company
语种：
外文
被引次数：
WOS：
中科院(CAS)分区：
出版当年[2014]版：
大类 | 2 区 医学
小类 | 3 区 内分泌学与代谢
最新[2025]版：
大类 | 2 区 医学
小类 | 2 区 内分泌学与代谢
JCR分区：
出版当年[2013]版：
Q1 ENDOCRINOLOGY & METABOLISM
最新[2023]版：
Q1 ENDOCRINOLOGY & METABOLISM

影响因子： 最新[2023版] 最新五年平均[2021-2025] 出版当年[2013版] 出版当年五年平均[2009-2013] 出版前一年[2012版] 出版后一年[2014版]

第一作者：
第一作者单位： [1]Shanghai Jiao Tong Univ, Peoples Hosp 6, Metab Bone Dis & Genet Res Unit, Dept Osteoporosis & Bone Dis, Shanghai 200233, Peoples R China [*1]Shanghai Jiao Tong Univ, Peoples Hosp 6, Metab Bone Dis & Genet Res Unit, Dept Osteoporosis & Bone Dis, 600 Yi Shan Rd, Shanghai 200233, Peoples R China
通讯作者：
通讯机构： [1]Shanghai Jiao Tong Univ, Peoples Hosp 6, Metab Bone Dis & Genet Res Unit, Dept Osteoporosis & Bone Dis, Shanghai 200233, Peoples R China [*1]Shanghai Jiao Tong Univ, Peoples Hosp 6, Metab Bone Dis & Genet Res Unit, Dept Osteoporosis & Bone Dis, 600 Yi Shan Rd, Shanghai 200233, Peoples R China
推荐引用方式(GB/T 7714)：
Zhang Z. L.,Liao E. Y.,Xia W. B.,et al.Alendronate sodium/vitamin D-3 combination tablet versus calcitriol for osteoporosis in Chinese postmenopausal women: a 6-month, randomized, open-label, active-comparator-controlled study with a 6-month extension[J].OSTEOPOROSIS INTERNATIONAL.2015,26(9):2365-2374.doi:10.1007/s00198-015-3141-y.
APA：
Zhang, Z. L.,Liao, E. Y.,Xia, W. B.,Lin, H.,Cheng, Q....&Santora, A. C..(2015).Alendronate sodium/vitamin D-3 combination tablet versus calcitriol for osteoporosis in Chinese postmenopausal women: a 6-month, randomized, open-label, active-comparator-controlled study with a 6-month extension.OSTEOPOROSIS INTERNATIONAL,26,(9)
MLA：
Zhang, Z. L.,et al."Alendronate sodium/vitamin D-3 combination tablet versus calcitriol for osteoporosis in Chinese postmenopausal women: a 6-month, randomized, open-label, active-comparator-controlled study with a 6-month extension".OSTEOPOROSIS INTERNATIONAL 26..9(2015):2365-2374

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