单位：[1]Department of Endocrinology, Peking Union Medical College Hospital, Beijing, China[2]Beijing Friendship Hospital Capital Medical University, Beijing, China首都医科大学附属北京友谊医院[3]Tianjin Hospital, Tianjin, China[4]Huadong Hospital affiliated to Fudan University, Shanghai, China[5]Nanjing Drum Tower Hospital Affiliated of Nanjing University Medical School, Nanjing, China[6]Chengdu Military General Hospital, Chengdu, China[7]Shanghai Sixth People Hospital, Shanghai, China[8]Chugai Pharmaceutical Co., Ltd., Tokyo, Japan[9]Fujii Memorial Institute of Medical Sciences, Tokushima University, Tokushima, Japan[10]Department of Radiology, Peking Union Medical College Hospital, Beijing, China[11]Department of Nutrition, Peking Union Medical College Hospital, Beijing, China
Eldecalcitol increased bone mineral density (BMD) and prevented vertebral fractures in vitamin D-sufficient osteoporotic subjects. However, the effect of eldecalcitol on BMD under vitamin D insufficiency is unknown. We examined the effect of eldecalcitol on BMD compared with alfacalcidol in osteoporotic patients without vitamin D or calcium supplementation. This is a randomized, double-blind, active comparator trial. 265 Chinese osteoporotic patients were randomly assigned to receive 0.75 mu g eldecalcitol or 1.0 mu g alfacalcidol for 12 months without vitamin D or calcium supplementation. Baseline calcium intakes were less than 550 mg/day and mean serum 25-hydroxyvitamin D [25(OH)D] was below 43 nmol/L in both groups. Baseline BMD tended to be lower in patients with lower calcium intake and serum 25(OH)D. Lumbar BMD increased by 2.05% higher in eldecalcitol than alfacalcidol group at 12 months. Total hip and femoral neck BMD also increased by 1.33 and 1.78%, respectively, in the eldecalcitol than the alfacalcidol group. The effect of eldecalcitol on BMD was not affected by serum 25(OH)D or calcium intake. The incidence of adverse events was not different between the two groups. Incidence of hypercalcemia in the edecalcitol group was not affected by serum 25(OH)D. In conclusion, baseline BMD tended to be lower in patients with low calcium intake and serum 25(OH)D. Eldecalcitol increased lumbar and hip BMD more than alfacalcidol regardless of serum 25(OH)D or calcium intake without vitamin D or calcium supplementation. These results suggest that eldecalcitol is effective in increasing the BMD of osteoporotic patients regardless of vitamin D status or calcium intake. Clinical Trial Registration number JAPIC CTI 152904.
基金：
Chugai Pharmaceutical Co., Ltd.
语种：
外文
被引次数：
WOS：
PubmedID：
中科院(CAS)分区：
出版当年[2018]版：
大类|3 区医学
小类|4 区内分泌学与代谢4 区医学：研究与实验
最新[2025]版：
大类|4 区医学
小类|4 区内分泌学与代谢4 区医学：研究与实验
JCR分区：
出版当年[2017]版：
Q3MEDICINE, RESEARCH & EXPERIMENTALQ3ENDOCRINOLOGY & METABOLISM
最新[2023]版：
Q3ENDOCRINOLOGY & METABOLISMQ3MEDICINE, RESEARCH & EXPERIMENTAL
第一作者单位：[1]Department of Endocrinology, Peking Union Medical College Hospital, Beijing, China
通讯作者：
推荐引用方式(GB/T 7714)：
Yan Jiang,Hai Tang,Xinlong Ma,et al.Eldecalcitol increases bone mineral density in Chinese osteoporotic patients without vitamin D or calcium supplementation[J].JOURNAL of BONE and MINERAL METABOLISM.2019,37(6):1036-1047.doi:10.1007/s00774-019-01009-9.
APA：
Yan Jiang,Hai Tang,Xinlong Ma,Qun Cheng,Hua Lin...&Weibo Xia.(2019).Eldecalcitol increases bone mineral density in Chinese osteoporotic patients without vitamin D or calcium supplementation.JOURNAL of BONE and MINERAL METABOLISM,37,(6)
MLA：
Yan Jiang,et al."Eldecalcitol increases bone mineral density in Chinese osteoporotic patients without vitamin D or calcium supplementation".JOURNAL of BONE and MINERAL METABOLISM 37..6(2019):1036-1047
