IR@PKUHSC  > 北京大学第二临床医学院
学科主题临床医学
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
Zhang, Z. L.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
关键词Alendronate Calcitriol China Postmenopausal osteoporosis Vitamin D
刊名OSTEOPOROSIS INTERNATIONAL
2015-09-01
DOI10.1007/s00198-015-3141-y
26期:9页:2365-2374
收录类别SCI
文章类型Article
WOS标题词Science & Technology
类目[WOS]Endocrinology & Metabolism
资助者MSD China Holding Co., Ltd., China ; Merck &amp ; Co., Inc., Whitehouse Station, NJ, USA ; MSD China Holding Co., Ltd., China ; Merck &amp ; Co., Inc., Whitehouse Station, NJ, USA
研究领域[WOS]Endocrinology & Metabolism
关键词[WOS]BONE-MINERAL DENSITY ; VITAMIN-D INSUFFICIENCY ; 70 MG ; VERTEBRAL FRACTURES ; TURNOVER MARKERS ; D DEFICIENCY ; TRIAL ; RISK ; PREVALENCE ; RALOXIFENE
英文摘要

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.

语种英语
资助者MSD China Holding Co., Ltd., China ; Merck &amp ; Co., Inc., Whitehouse Station, NJ, USA ; MSD China Holding Co., Ltd., China ; Merck &amp ; Co., Inc., Whitehouse Station, NJ, USA
WOS记录号WOS:000359475200017
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/400002259/66199
Collection北京大学第二临床医学院
作者单位1.Fudan Univ, Huadong Hosp, Shanghai 200433, Peoples R China
2.Merck Res Labs, Rahway, NJ USA
3.Peking Univ, Peoples Hosp, Beijing 100871, Peoples R China
4.Peking Univ, Third Hosp, Beijing 100871, Peoples R China
5.Merck Sharp & Dohme China, Global Med Affairs, Shanghai, Peoples R China
6.Tianjin Hosp, Tianjin, Peoples R China
7.Shanghai Ninth Peoples Hosp, Shanghai, Peoples R China
8.Shanghai First Peoples Hosp, Shanghai, Peoples R China
9.Beijing Jishuitan Hosp, Beijing, Peoples R China
10.Nanjing Drum Tower Hosp, Nanjing, Jiangsu, Peoples R China
11.Shanghai Jiao Tong Univ, Peoples Hosp 6, Metab Bone Dis & Genet Res Unit, Dept Osteoporosis & Bone Dis, Shanghai 200233, Peoples R China
12.Cent S Univ, Xiangya Hosp 2, Changsha, Hunan, Peoples R China
13.Beijing Union Med Coll Hosp, Beijing, Peoples R China
14.Sichuan Univ, West China Sch Med, West China Hosp, Chengdu 610064, Peoples R China
15.Capital Med Univ, Beijing Friendship Hosp, Beijing, Peoples R China
Recommended Citation
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.
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),2365-2374.
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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