Clinical characteristics associated with bone mineral density improvement after 1-year alendronate/vitamin d(3) or calcitriol treatment Exploratory results from a phase 3, randomized, controlled trial on postmenopausal osteoporotic women in China
单位：[1]The Second Xiangya Hospital, Central South University, Changsha[2]The Sixth People’s Hospital, Shanghai Jiaotong University[3]Peking Union Medical College Hospital[4]Nanjing Drum Tower Hospital, Nanjing[5]Huadong Hospital Affiliated to Fudan University[6]Tianjin Hospital, Tianjin[7]The Ninth People’s Hospital[8]West China Hospital, West China School of Medicine, Sichuan University, Chengdu四川大学华西医院[9]Beijing Friendship Hospital, Capital Medical University首都医科大学附属北京友谊医院[10]The First People’s Hospital, k Beijing Jishuitan Hospital[11]Peking University People’s Hospital[12]Peking University Third Hospital, Beijing[13]Global Medical Affairs, Merck Sharp & Dohme China, Shanghai, China.
Baseline and on-treatment characteristics, including age, obesity, calcium intake, and bone turnover markers, may predict the bone mineral density (BMD) response in women with postmenopausal osteoporosis (PMO) to 1 to 2 years of antiresorptive therapy and/or vitamin D supplementation. This study aimed to explore clinical characteristics associated with 12-month BMD improvement in Chinese women with postmenopausal osteoporosis (PMO). In this post hoc analysis of a previous phase 3 multicenter, randomized controlled trial, Chinese PMO women who were treated with once weekly alendronate 70mg/vitamin D3 5600 IU (ALN/D5600) or once daily calcitriol 0.25mcg, and had measurements of 1-year lumbar spine BMD (LS-BMD) and on-treatment bone turnover markers (BTMs) were included in the analysis. In Chinese PMO patients on ALN/D5600, 1-year LS-BMD change was negatively correlated with age (beta= -0.00084, P < .01), dietary calcium (beta = -0.0017, P = .07), and procollagen type 1 N-terminal propeptide (P1NP) change at month 6 (beta = -0.000469, P = .0016), but positively with body mass index (BMI) (beta = 0.00128, P = .08); baseline P1NP above the median was associated with a significantly greater BMD percentage change at the lumbar spine (P = .02) and the total hip (P = .0001). In the calcitriol group, a significant 1-year LS-BMD increase was associated with BMI (beta = 0.0023, P = .02), baseline P1NP (beta = 0.00035, P = .0067), history of prior vertebral fracture(s) (beta = 0.034, P < .0001) and baseline serum 25(OH)D level (beta = -0.00083, P = .02). The presented findings from Chinese postmenopausal osteoporotic women suggested clinically meaningful baseline and on-treatment characteristics predicting BMD improvement after 1 year of ALN/D5600 treatment, which differed from calcitriol treatment with baseline identifiable associations. The study remained exploratory and further accumulation of evidence is needed.
第一作者单位：[1]The Second Xiangya Hospital, Central South University, Changsha
通讯作者：
通讯机构：[3]Peking Union Medical College Hospital[*1]Department of Endocrinology, Key Laboratory of Endocrinology, Ministry of Health, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Shuaifuyuan No. 1, Wangfujing, Dongcheng District, Beijing 100730, China
推荐引用方式(GB/T 7714)：
Liao Er-Yuan,Zhang Zhen-Lin,Xia Wei-Bo,et al.Clinical characteristics associated with bone mineral density improvement after 1-year alendronate/vitamin d(3) or calcitriol treatment Exploratory results from a phase 3, randomized, controlled trial on postmenopausal osteoporotic women in China[J].MEDICINE.2018,97(31):doi:10.1097/MD.0000000000011694.
APA：
Liao, Er-Yuan,Zhang, Zhen-Lin,Xia, Wei-Bo,Lin, Hua,Cheng, Qun...&Zhang, Lei.(2018).Clinical characteristics associated with bone mineral density improvement after 1-year alendronate/vitamin d(3) or calcitriol treatment Exploratory results from a phase 3, randomized, controlled trial on postmenopausal osteoporotic women in China.MEDICINE,97,(31)
MLA：
Liao, Er-Yuan,et al."Clinical characteristics associated with bone mineral density improvement after 1-year alendronate/vitamin d(3) or calcitriol treatment Exploratory results from a phase 3, randomized, controlled trial on postmenopausal osteoporotic women in China".MEDICINE 97..31(2018)
