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Eldecalcitol increases bone mineral density in Chinese osteoporotic patients without vitamin D or calcium supplementation.

Authors
  • Jiang, Yan1
  • Tang, Hai2
  • Ma, Xinlong3
  • Cheng, Qun4
  • Lin, Hua5
  • Jin, Xiaolan6
  • Zhang, Zhenlin7
  • Yu, Wei8
  • He, Shuli9
  • Kobayashi, Tsuyoshi10
  • Uehara, Satomi10
  • Matsumoto, Toshio11
  • Xia, Weibo12
  • 1 Department of Endocrinology, Peking Union Medical College Hospital, Beijing, China. , (China)
  • 2 Beijing Friendship Hospital Capital Medical University, Beijing, China. , (China)
  • 3 Tianjin Hospital, Tianjin, China. , (China)
  • 4 Huadong Hospital affiliated to Fudan University, Shanghai, China. , (China)
  • 5 Nanjing Drum Tower Hospital Affiliated of Nanjing University Medical School, Nanjing, China. , (China)
  • 6 Chengdu Military General Hospital, Chengdu, China. , (China)
  • 7 Shanghai Sixth People Hospital, Shanghai, China. , (China)
  • 8 Department of Radiology, Peking Union Medical College Hospital, Beijing, China. , (China)
  • 9 Department of Nutrition, Peking Union Medical College Hospital, Beijing, China. , (China)
  • 10 Chugai Pharmaceutical Co., Ltd., Tokyo, Japan. , (Japan)
  • 11 Fujii Memorial Institute of Medical Sciences, Tokushima University, Tokushima, Japan. [email protected] , (Japan)
  • 12 Department of Endocrinology, Peking Union Medical College Hospital, Beijing, China. [email protected] , (China)
Type
Published Article
Journal
Journal of Bone and Mineral Metabolism
Publisher
Springer-Verlag
Publication Date
Nov 01, 2019
Volume
37
Issue
6
Pages
1036–1047
Identifiers
DOI: 10.1007/s00774-019-01009-9
PMID: 31087185
Source
Medline
Keywords
Language
English
License
Unknown

Abstract

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 μg eldecalcitol or 1.0 μg 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.

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