Eldecalcitol and calcium supplementation in Chinese women with postmenopausal osteoporosis: a prospective observational cohort study
16 affiliations
- 1Peking Union Medical College Hospital, No.1 Shuai-Fu-Yuan, Beijing, 100730 China
- 2Xi’an Hong Hui Hospital, No.555 East Youyi Road Nanshao Gate anguo Road No.76, Xi’an, 710054 Shanxi China
- 3The Affiliated Hospital of Xuzhou Medical University, No.99 West Huaihai Road, Xuzhou, 221006 Jiangsu China
- 4Xinyi Hospital of Traditional Chinese Medicine, No.168 Daqiao Dong Lu, Xinyi, 221416 Jiangsu China
- 5The Second Affiliated Hospital of Soochow University, No.1055 Sanxiang Road Gusu District, Suzhou, 215004 Jiangsu China
- 6Zhangjiagang First People’s Hospital, No.68, Jiyang West Road, Zhangjiagang, 215638 Jiangsu China
- 7Wenzhou TCM Hospital of Zhejiang Chinese Medical University, No.9, Jiaowei Road, Liuhongqiao Nanjiao Street, Lucheng District, Wenzhou, 325088 Zhejiang China
- 8First People’s Hospital of Jinan, No.132 Daminghu Road, Lixia District, Jinan, 250011 Shandong China
- 9The Second Hospital of Shandong University, 247 Beiyuan Dajie, Jinan, 250011 Shandong China
- 10ZhongShan Chen Xinghai Hospital of Integrated Traditional Chinese and Western Medicine, No.18 Zhuyuan Road, Xiaolan Town, Zhongshan, 314408 Guangdong China
- 11Zhejiang Provincial People’s Hospital, No.158 Shangtang Road Gongshu District, Hangzhou, 528455 Zhejiang China
- 12Safety Science 2 Department, Drug Safety Division, Chugai Pharmaceutical Co., Ltd., 1‑1 Nihonbashi‑Muromachi 2-Chome, Chuo-ku, Tokyo 103‑8324 Japan
- 13Safety Science 1 Department, Drug Safety Division, Chugai Pharmaceutical Co., Ltd., 1‑1 Nihonbashi‑Muromachi 2-Chome, Chuo-ku, Tokyo 103‑8324 Japan
- 14Medical Division, Chugai Pharma China Co., Ltd., Unit 5702, Hong Kong New World Tower, No.300, Central Huai Hai Road, Huangpu District, Shanghai, 200021 China
- 15Toranomon Hospital Kajigaya, 1-3-1 Kajigaya, Takatsu-ku, Kawasaki, Kanagawa 213-8587 Japan
- 16Okinaka Memorial Institute for Medical Research, 2‑2‑2 Toranomon, Minato‑ku, Tokyo 105‑8470 Japan
Abstract
Introduction: Eldecalcitol is an active vitamin D3 derivative approved for the treatment of osteoporosis in Japan and postmenopausal osteoporosis in China. However, the impact of concomitant calcium supplementation on its safety profile is unclear.
Materials and methods: This was a prospective, observational, non-interventional post-marketing drug intensive monitoring study in Chinese postmenopausal women with osteoporosis (NCT05433207). Data were collected using an electronic case report form at baseline, before initial eldecalcitol dosing, and during routine clinical visits over a 1-year follow-up period.
Results: One thousand patients were enrolled from 29 Chinese clinical sites; 958 received eldecalcitol (853 without/105 with calcium supplementation). The mean age (standard deviation [SD]) of patients was 65.6 (9.0) years and mean (SD) time since osteoporosis diagnosis was 2.7 (3.8) years. Adverse drug reactions (ADRs) affected 39.2% and 42.9% of patients in the without and with calcium supplementation groups, respectively. 22 (2.3%) patients developed hypercalcemia including 17 (1.99%) and 5 (4.76%) in the without and with calcium supplementation groups, respectively. Multivariable logistic regression analyses indicated that those receiving calcium were more likely to experience hypercalcemia (adjusted odds ratio [OR] 3.07, 95% confidence interval [CI] 1.16, 8.10, P = 0.02) than those not receiving calcium. ADRs of urolithiasis were experienced by three patients (0.35%) in the without calcium supplementation group.
Conclusion: This study confirmed the real-world safety profile of eldecalcitol in a large population of Chinese women with postmenopausal osteoporosis. Hypercalcemia incidence was higher in patients with compared to without calcium supplementation, indicating that concomitant eldecalcitol and calcium should be carefully considered.
Supplementary Information: The online version contains supplementary material available at https://doi.org/10.1007/s00774-026-01735-x.
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BibTeX
@article{jiang2026eldecalcitol,
title = {{Eldecalcitol and calcium supplementation in Chinese women with postmenopausal osteoporosis: a prospective observational cohort study}},
author = {Yan Jiang and Yuhong Zeng and Li Xin and Wei Chen and Youjia Xu and Shoujin Tian and Qinglai Wang and Jianjun Li and Shihong Chen and Xuanxia Lin and Qifeng Ying and Shun Chiba and Chiemi Yamagiwa and Tomohiro Yamaguchi and Zheng Ke and Weibo Xia and Yasuhiro Takeuchi},
journal = {Journal of Bone and Mineral Metabolism},
year = {2026},
month = jun,
doi = {10.1007/s00774-026-01735-x},
url = {https://doi.org/10.1007/s00774-026-01735-x},
note = {CC BY 4.0},
}
RIS
TY - JOUR
TI - Eldecalcitol and calcium supplementation in Chinese women with postmenopausal osteoporosis: a prospective observational cohort study
AU - Yan Jiang
AU - Yuhong Zeng
AU - Li Xin
AU - Wei Chen
AU - Youjia Xu
AU - Shoujin Tian
AU - Qinglai Wang
AU - Jianjun Li
AU - Shihong Chen
AU - Xuanxia Lin
AU - Qifeng Ying
AU - Shun Chiba
AU - Chiemi Yamagiwa
AU - Tomohiro Yamaguchi
AU - Zheng Ke
AU - Weibo Xia
AU - Yasuhiro Takeuchi
PY - 2026
DA - 2026/06/16
JO - Journal of Bone and Mineral Metabolism
DO - 10.1007/s00774-026-01735-x
UR - https://doi.org/10.1007/s00774-026-01735-x
AB - Introduction: Eldecalcitol is an active vitamin D3 derivative approved for the treatment of osteoporosis in Japan and postmenopausal osteoporosis in China. However, the impact of concomitant calcium supplementation on its safety profile is unclear. Materials and methods: This was a prospective, observational, non-interventional post-marketing drug intensive monitoring study in Chinese postmenopausal women with osteoporosis (NCT05433207). Data were collected using an electronic case report form at baseline, before initial eldecalcitol dosing, and during routine clinical visits over a 1-year follow-up period. Results: One thousand patients were enrolled from 29 Chinese clinical sites; 958 received eldecalcitol (853 without/105 with calcium supplementation). The mean age (standard deviation [SD]) of patients was 65.6 (9.0) years and mean (SD) time since osteoporosis diagnosis was 2.7 (3.8) years. Adverse drug reactions (ADRs) affected 39.2% and 42.9% of patients in the without and with calcium supplementation groups, respectively. 22 (2.3%) patients developed hypercalcemia including 17 (1.99%) and 5 (4.76%) in the without and with calcium supplementation groups, respectively. Multivariable logistic regression analyses indicated that those receiving calcium were more likely to experience hypercalcemia (adjusted odds ratio [OR] 3.07, 95% confidence interval [CI] 1.16, 8.10, P = 0.02) than those not receiving calcium. ADRs of urolithiasis were experienced by three patients (0.35%) in the without calcium supplementation group. Conclusion: This study confirmed the real-world safety profile of eldecalcitol in a large population of Chinese women with postmenopausal osteoporosis. Hypercalcemia incidence was higher in patients with compared to without calcium supplementation, indicating that concomitant eldecalcitol and calcium should be carefully considered. Supplementary Information: The online version contains supplementary material available at https://doi.org/10.1007/s00774-026-01735-x.
SN - 0914-8779
SN - 1435-5604
ER -