Title |
Calcifediol (25-hydroxyvitamin D) improvement and calcium-phosphate metabolism of alendronate sodium/vitamin D3 combination in Chinese women with postmenopausal osteoporosis: a post hoc efficacy analysis and safety reappraisal
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Published in |
BMC Musculoskeletal Disorders, July 2018
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DOI | 10.1186/s12891-018-2090-y |
Pubmed ID | |
Authors |
Er-Yuan Liao, Zhen-Lin Zhang, Wei-Bo Xia, Hua Lin, Qun Cheng, Li Wang, Yong-Qiang Hao, De-Cai Chen, Hai Tang, Yong-De Peng, Li You, Liang He, Zhao-Heng Hu, Chun-Li Song, Fang Wei, Jue Wang, Lei Zhang |
Abstract |
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 D3 (ALN/D5600). 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. 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%). Baseline VD status predicted 25(OH) D improvement in PMO patients on 12-month ALN/D5600 treatment. The daily use of 0.25 μg 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. |
X Demographics
Geographical breakdown
Country | Count | As % |
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Colombia | 1 | 50% |
United States | 1 | 50% |
Demographic breakdown
Type | Count | As % |
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Members of the public | 1 | 50% |
Practitioners (doctors, other healthcare professionals) | 1 | 50% |
Mendeley readers
Geographical breakdown
Country | Count | As % |
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Unknown | 65 | 100% |
Demographic breakdown
Readers by professional status | Count | As % |
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Student > Bachelor | 11 | 17% |
Student > Master | 4 | 6% |
Other | 3 | 5% |
Researcher | 3 | 5% |
Student > Ph. D. Student | 3 | 5% |
Other | 8 | 12% |
Unknown | 33 | 51% |
Readers by discipline | Count | As % |
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Medicine and Dentistry | 9 | 14% |
Biochemistry, Genetics and Molecular Biology | 4 | 6% |
Nursing and Health Professions | 3 | 5% |
Sports and Recreations | 3 | 5% |
Agricultural and Biological Sciences | 2 | 3% |
Other | 7 | 11% |
Unknown | 37 | 57% |