Clinical characteristics associated with bone mineral density improvement after 1-year alendronate/vitamin d3 or calcitriol treatment Exploratory results from a phase 3, randomized, controlled trial on postmenopausal osteoporotic women in China

被引：14

作者：

Liao, Er-Yuan ^{[1
]}

Zhang, Zhen-Lin ^{[2
]}

Xia, Wei-Bo ^{[3
]}

Lin, Hua ^{[4
]}

Cheng, Qun ^{[5
]}

Wang, Li ^{[6
]}

Hao, Yong-Qiang ^{[7
]}

Chen, De-Cai ^{[8
]}

Tang, Hai ^{[9
]}

Peng, Yong-De ^{[10
]}

You, Li ^{[10
]}

He, Liang ^{[11
]}

Hu, Zhao-Heng ^{[12
]}

Song, Chun-Li ^{[13
]}

Wei, Fang ^{[14
]}

Wang, Jue ^{[14
]}

Zhang, Lei ^{[14
]}

机构：

[1] Cent S Univ, Xiangya Hosp 2, Changsha, Hunan, Peoples R China

[2] Shanghai Jiao Tong Univ, Peoples Hosp 6, Shanghai, 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, Peoples R China

[6] Tianjin Hosp, Tianjin, Peoples R China

[7] Ninth Peoples Hosp, Shanghai, Peoples R China

[8] Sichuan Univ, West China Sch Med, West China Hosp, Chengdu, Sichuan, Peoples R China

[9] Capital Med Univ, Beijing Friendship Hosp, Beijing, Peoples R China

[10] First Peoples Hosp, Shanghai, Peoples R China

[11] Beijing Jishuitan Hosp, Beijing, Peoples R China

[12] Peking Univ, Peoples Hosp, Beijing, Peoples R China

[13] Peking Univ, Hosp 3, Beijing, Peoples R China

[14] Merck Sharp & Dohme China, Global Med Affairs, Shanghai, Peoples R China

来源：

MEDICINE | 2018年 / 97卷 / 31期

关键词：

alendronate sodium; bone mineral density; bone turnover biomarker; calcitriol; post hoc analysis; postmenopausal osteoporosis; VITAMIN-D STATUS; BIOCHEMICAL MARKERS; D SUPPLEMENTATION; TURNOVER PREDICT; D DEFICIENCY; FRACTURES; THERAPY; CALCIUM; RISK; MASS;

D O I：

10.1097/MD.0000000000011694

中图分类号：

R5 [内科学];

学科分类号：

100201 [内科学];

摘要：

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.

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