Calcifediol (25-hydroxyvitamin D) improvement and calcium-phosphate metabolism of alendronate sodium/vitamin D-3 combination in Chinese women with postmenopausal osteoporosis: a post hoc efficacy analysis and safety reappraisal
单位：[1]The Second Xiangya Hospital, Central South University, Changsha, China[2]The Sixth People’s Hospital, Shanghai Jiaotong University, Shanghai, China[3]Department of Endocrinology, Key Laboratory of Endocrinology, Ministry ofHealth, Peking Union Medical College Hospital, Chinese Academy of MedicalSciences, Shuaifuyuan No. 1, Wangfujing, Dongcheng District, Beijing 100730,China[4]Nanjing Drum Tower Hospital, Nanjing, China[5]Huadong HospitalAffiliated to Fudan University, Shanghai, China[6]Tianjin Hospital, Tianjin,China[7]The Ninth People’s Hospital, Shanghai, China[8]West China Hospital,West China School of Medicine, Sichuan University, Chengdu, China四川大学华西医院[9]BeijingFriendship Hospital, Capital Medical University, Beijing, China首都医科大学附属北京友谊医院[10]The First People’s Hospital, Shanghai, China[11]Beijing Jishuitan Hospital, Beijing, China[12]Peking University People’s Hospital, Beijing, China[13]Peking University ThirdHospital, Beijing, China[14]Global Medical Affairs, Merck Sharp & Dohme China, Shanghai, China.
Background: Vitamin D (VD) insufficiency or deficiency is a frequent comorbidity in Chinese women with postmenopausal osteoporosis (PMO). The present study aimed to investigate 25-hydroxyvitamin D [25(OH)D] improvement and calcium-phosphate metabolism in Chinese PMO patients treated with 70 mg of alendronate sodium and 5600 IU of vitamin D-3 (ALN/D5600). Methods: Chinese PMO women (n = 219) were treated with 12-month ALN/D5600 (n =111) or calcitriol (n = 108). Changes in 25(OH) D at month 12 were post hoc analyzed by the baseline 25 (OH)D status using the longitudinal analysis. The main safety outcome measures included serum calcium and phosphate and 24-h urine calcium, and the repeated measures mixed model was used to assess the frequencies of the calcium-phosphate metabolic disorders. Results: Absolute change in mean serum 25(OH) D level was the greatest in VD-deficient patients and least in VD-sufficient patients at months six and 12 (both, P < 0.01). Serum calcium level remained significantly lower in the ALN/D5600 treatment group than in the calcitriol treatment group throughout the 12 months. Mean 24-h urine calcium slightly increased in the ALN/D5600 treatment group and significantly increased in the calcitriol treatment group (+ 1.1 and + 0.9 mmol/L at months six and 12; both, P < 0.05). Calcitriol treatment was associated with more frequent hypercalciuria at month six (9.4% vs. 18.5%, P= 0.05), but not at month 12 (12.3% vs. 13.0%). Conclusion: Baseline VD status predicted 25(OH) D improvement in PMO patients on 12-month ALN/D5600 treatment. The daily use of 0.25 mu g of calcitriol was associated with more frequent hypercalciuria at month six, compared to ALN/5600 treatment, necessitating the safety re-evaluation of calcitriol at a higher dosage.
第一作者单位：[1]The Second Xiangya Hospital, Central South University, Changsha, China
通讯作者：
推荐引用方式(GB/T 7714)：
Liao Er-Yuan,Zhang Zhen-Lin,Xia Wei-Bo,et al.Calcifediol (25-hydroxyvitamin D) improvement and calcium-phosphate metabolism of alendronate sodium/vitamin D-3 combination in Chinese women with postmenopausal osteoporosis: a post hoc efficacy analysis and safety reappraisal[J].BMC MUSCULOSKELETAL DISORDERS.2018,19:doi:10.1186/s12891-018-2090-y.
APA：
Liao, Er-Yuan,Zhang, Zhen-Lin,Xia, Wei-Bo,Lin, Hua,Cheng, Qun...&Zhang, Lei.(2018).Calcifediol (25-hydroxyvitamin D) improvement and calcium-phosphate metabolism of alendronate sodium/vitamin D-3 combination in Chinese women with postmenopausal osteoporosis: a post hoc efficacy analysis and safety reappraisal.BMC MUSCULOSKELETAL DISORDERS,19,
MLA：
Liao, Er-Yuan,et al."Calcifediol (25-hydroxyvitamin D) improvement and calcium-phosphate metabolism of alendronate sodium/vitamin D-3 combination in Chinese women with postmenopausal osteoporosis: a post hoc efficacy analysis and safety reappraisal".BMC MUSCULOSKELETAL DISORDERS 19.(2018)
