Abstract
Introduction
Romosozumab reportedly increases bone mineral density (BMD) potently but might adversely affect cardiovascular disease (CVD). We evaluated the efficacy of romosozumab in osteoporotic HD patients with a high risk of fracture.
Materials and methods
This was a single-center 1-year study in Japanese HD patients. Among 96 HD romosozumab-treated HD patients with high risk of fracture, 76 HD patients completed 1 year of subcutaneous administration of romosozumab (210 mg/4 weeks) for 1 year. Romosozumab-untreated HD patients (n = 55) were also included. Changes in BMD and serum markers, together with fracture occurrence, and CVD events, were monitored.
Results
During romosozumab treatment of 76 HD patients, BMD time-dependently increased significantly by 15.3% ± 12.9% at the lumbar spine (L1–4), and 7.2% ± 8.3% at the femoral neck at 1 year. Serum BAP and total P1NP increased significantly and serum TRACP-5b decreased at 4 weeks. Fragility fractures occurred in three (3.8%) patients. Hypocalcemia occurred at 4–48 weeks despite the increased dosing of active vitamin-D derivatives, but without any symptom. New CVD events occurred in 5.2% of romosozumab-treated HD patients and10.9% in romosozumab-untreated HD patients.
Conclusions
BMD was increased significantly during romosozumab treatment at the lumbar spine, and the femoral neck, respectively, at 1 year in HD patients. Hypocalcemia occurred but without any intolerable event. There was no apparent increase in CVD events during 1 year of study, suggesting romosozumab as a promising agent for HD patients with severe osteoporosis.
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MS: contributed to the study design, performed study, data analysis, drafted the main manuscript, and provided final approval for submission; MI: contributed to the study design, performed study, data analysis, reviewed the manuscript critically for important intellectual content, and provided final approval for submission; SY: contributed to performed data analysis, and provided final approval for submission; ME: reviewed the manuscript critically for important intellectual content and provided final approval for submission; YO: reviewed the manuscript critically for important intellectual content, and provided final approval for submission; and YT: reviewed the manuscript critically for important intellectual content, and provided final approval.
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M. S. has received personal fees from Amgen. M. I. has received lecture fee from Daiichi Sankyo. S. Y., Y. O., M. E., and Y. T. have nothing to disclose.
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The protocol was approved by the Ethics Review Committee of Inoue Hospital (Approval #250) and conducted in accordance with the principles of the Declaration of Helsinki. All patients provided consent to participate in this study.
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All patients provided consent to participate in this study and written informed consent was obtained from each participant prior to participation.
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Sato, M., Inaba, M., Yamada, S. et al. Efficacy of romosozumab in patients with osteoporosis on maintenance hemodialysis in Japan; an observational study. J Bone Miner Metab 39, 1082–1090 (2021). https://doi.org/10.1007/s00774-021-01253-y
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DOI: https://doi.org/10.1007/s00774-021-01253-y