Abstract
Introduction
Eldecalcitol (ELD) is an active vitamin D3 analog (AVD) commonly used to treat osteoporosis in Japan. Although routine monitoring of serum calcium levels during ELD therapy is recommended, little is known about the actual frequency and determinants of monitoring.
Materials and methods
This was a descriptive cohort study using a Japanese electronic medical records database. We identified osteoporosis patients who initiated treatment with ELD or other AVDs (alfacalcidol and calcitriol) between April 1, 2011 and September 10, 2021. The index date for cohort entry was the first prescription date of ELD or other AVDs. The frequency of serum calcium monitoring was evaluated every 6 months. Determinants of serum calcium monitoring were identified using multivariable logistic regression models. We also calculated the incidence of hypercalcemia and the frequency of serum calcium monitoring within 6 months before hypercalcemia.
Results
We identified 12,671 ELD users and 7867 other AVD users. Within 6 months after cohort entry, 45.9% of ELD users and 58.7% of other AVD users underwent serum calcium monitoring. Female sex, no use of systemic corticosteroids, moderate-to-good renal function, treatment in smaller hospitals, and treatment in orthopedic surgery departments were associated with a lower likelihood of receiving serum calcium monitoring during ELD therapy. The incidence of hypercalcemia among ELD users was 6.36 per 100 person-years, with 20.6% of cases not receiving serum calcium monitoring before hypercalcemia.
Conclusion
Our findings suggest that serum calcium monitoring is not given adequate attention during ELD therapy in routine clinical practice.
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Acknowledgements
The authors are grateful to Dr. Guy Harris of Dmed (< www.dmed.co.jp >) for his support with the writing of the manuscript. This research was not supported by any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.
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All authors were involved in formulating the study concept and design. KR performed the statistical analysis. KR and TF wrote the manuscript. All authors contributed to the discussion and reviewed, edited, and approved the final manuscript as submitted.
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Toshiki Fukasawa has been employed by the Department of Digital Health and Epidemiology, an Industry-Academia Collaboration Course supported by Eisai Co., Ltd., Kyowa Kirin Co., Ltd., and Real World Data Co., Ltd.; and has received consulting fees from Real World Data Co., Ltd. and speaker fees from Asahi Kasei Pharma Corporation and EPS Corporation. Shiro Tanaka has received lecture fees from Bayer Yakuhin, Amgen Astellas BioPharma K.K. and Research Institute of Healthcare Data Science; consulting fees from Boehringer Ingelheim; outsourcing fees from the Public Health Research Foundation; grants from Novo Nordisk Pharma Ltd., the Japan Agency for Medical Research and Development, the Japanese Ministry of Health Labor and Welfare, and the Japanese Ministry of Education, Science, and Technology. Masato Takeuchi has received consulting fees from Eisai Co., Ltd. Satomi Yoshida was employed by the Department of Digital Health and Epidemiology, an Industry-Academia Collaboration Course supported by Eisai Co., Ltd., Kyowa Kirin Co., Ltd., and Real World Data Co., Ltd.; and has received consulting fees from Real World Data Co., Ltd. Koji Kawakami has received research funds from Eisai Co., Ltd., Kyowa Kirin Co., Ltd., OMRON Corporation, Toppan Inc., and Real World Data Co., Ltd.; consulting fees from Advanced Medical Care Inc., JMDC Inc., and Shin Nippon Biomedical Laboratories Ltd.; executive compensation from Cancer Intelligence Care Systems, Inc.; honoraria from Chugai Pharmaceutical Co., Ltd., and Pharma Business Academy; and has held stock in Real World Data Co., Ltd. All other authors declare no potential conflicts of interest.
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Ri, K., Fukasawa, T., Masuda, S. et al. Frequency and determinants of serum calcium monitoring during eldecalcitol therapy in patients with osteoporosis. J Bone Miner Metab 41, 890–900 (2023). https://doi.org/10.1007/s00774-023-01470-7
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DOI: https://doi.org/10.1007/s00774-023-01470-7