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One-Year Romosozumab Treatment Followed by One-Year Denosumab Treatment for Osteoporosis in Patients on Hemodialysis: An Observational Study

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Abstract

There is limited evidence on the use of romosozumab (ROMO) in the treatment of osteoporosis in patients on hemodialysis (HD); thus, we aimed to investigate this topic. This prospective, observational, single-center cohort study included 13 prior osteoporosis treatment-naïve patients on HD with osteoporosis. They first received ROMO once monthly for 12 months (210 mg; subcutaneously once every month). Thereafter, they received denosumab (DENO) for an additional 12 months (60 mg; subcutaneously once every 6 months). We examined the incidence of new fractures; treatment safety; and temporal changes in the bone mineral density (BMD), bone metabolism markers, and vascular calcification. No new cases of fractures were noted. The median one-year percentage changes (from the baseline) in the BMDs at the lumbar spine (LS), total hip (TH), and femoral neck (FN) were + 9.0%, + 2.5%, and + 4.7%, respectively. These changes were maintained for 24 months. The corresponding relative changes from the baseline to 24 months thereafter were + 14.9%, + 5.4%, and + 6.5%, respectively. The percentage changes in TH BMD and FN BMD were negatively correlated with baseline BMD. Coronary artery and thoracic aorta calcification scores increased slightly from baseline to 12 months thereafter. However, fatal events (cardiovascular disease-associated and all-cause deaths) did not occur during ROMO treatment. Effectiveness of ROMO was better in patients who had severe osteoporosis with low TH BMD, low FN BMD, and high tartrate-resistant acid phosphatase 5b level at ROMO initiation.

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Data Availability

The datasets generated during and/or analyzed during the current study are not publicly available but are available from the corresponding author on reasonable request.

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Acknowledgements

The authors thank Ms. Miyoko Watanabe and the other staff members at the Sannoudai hospital for their assistance with data collaboration, data monitoring, and the conceptualization and execution of this study.

Funding

This study received no external funding.

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Authors and Affiliations

  1. Division of Nephrology, Department of Medicine, Showa University School of Medicine, 1-5-8 Hatanodai, Shinagawa-Ku, Tokyo, 142-8555, Japan

    Tomohiro Saito, Masahide Mizobuchi, Tadashi Kato, Taihei Suzuki & Hirokazu Honda

  2. Sannoudai Hospital, Isioka-Si, 4-1-38 Higasiishioka, Ibaraki, 315-0037, Japan

    Yasuro Fujiwara, Naoaki Kanamori & Mikio Makuuchi

Authors
  1. Tomohiro Saito
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  2. Masahide Mizobuchi
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  3. Tadashi Kato
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Contributions

Tomohiro Saito contributed to the study design, performed the study and data analysis, drafted the main manuscript, and provided the final approval for submission. Yasuro Fujiwara contributed to the study design and performed the study. Naoaki Kanamori contributed to the study design and performed the study. Masahide Mizobuchi reviewed the manuscript critically for important intellectual content and provided the final approval for submission. Mikio Makuuchi reviewed the manuscript critically for important intellectual content and provided the final approval for submission. Hirokazu Honda reviewed the manuscript critically for important intellectual content and provided the final approval for submission.

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Correspondence to Tomohiro Saito.

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Competing interests

Tomohiro Saito, Masahide Mizobuchi, Tadashi Kato, Taihei Suzuki, Yasuro Fujiwara, Naoaki Kanamori, Mikio Makuuchi, and Hirokazu Honda declare that they have no conflict of interest.

Human and Animal Rights and Informed Consent

The study protocol was approved by the ethical committee of the Showa University Hospital (No. 2896) and registered in the University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR ID: UMIN000039889). All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. All participants gave written informed consent. No animal studies were performed in the course of these experiments.

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Saito, T., Mizobuchi, M., Kato, T. et al. One-Year Romosozumab Treatment Followed by One-Year Denosumab Treatment for Osteoporosis in Patients on Hemodialysis: An Observational Study. Calcif Tissue Int 112, 34–44 (2023). https://doi.org/10.1007/s00223-022-01031-6

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