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08-07-2024 | Osteoporosis | Review Article

Efficacy and safety of romosozumab: a meta-analysis of placebo-controlled trials

Authors: Takaomi Kobayashi, Megumi Hara, Chisato Shimanoe, Tadatsugu Morimoto, Mawatari Masaaki, Koji Ito, Takafumi Shimazaki

Published in: Journal of Bone and Mineral Metabolism

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Abstract

Introduction

We aimed to comprehensively compile placebo-controlled trials on the efficacy and safety of romosozumab (210 mg, subcutaneously, once monthly) in postmenopausal women and men with osteoporosis.

Materials and methods

PubMed, Google Scholar, and ClinicalTrials.gov were searched for relevant placebo-controlled trials (as of January 1, 2024). Percent change in bone mineral density (BMD), falls, fractures, and adverse events (AEs) after drug administration were collected. Risk ratios (RRs) and mean differences (MDs) with 95% confidence intervals (CIs) were calculated.

Results

Six trials (7990 patients; follow-up period, 6–12 months) were included. Compared with placebo, romosozumab significantly increased lumbar spine BMD (MD = 12.69; 95% CI 11.10–14.29), total hip BMD (MD = 4.42; 95% CI 3.03–5.80), and femoral neck BMD (MD = 3.99; 95% CI 2.42–5.57) at 12 months. Romosozumab significantly decreased falls (RR = 0.80; 95% CI 0.68–0.93) and major osteoporotic fractures (RR = 0.37; 95% CI 0.25–0.54), but increased injection-site reactions (RR = 1.83; 95% CI 1.46–2.30) within 12 months. No significant differences were observed in other AEs (including cardiovascular AEs) within 12 months.

Conclusion

Romosozumab treatment resulted in a significant BMD gain, reduced falls and major osteoporotic fractures. It was generally well-tolerated, including the cardiovascular aspects. However, clinicians should consider the occurrence of minor AEs (e.g., injection-site reactions).
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Metadata
Title
Efficacy and safety of romosozumab: a meta-analysis of placebo-controlled trials
Authors
Takaomi Kobayashi
Megumi Hara
Chisato Shimanoe
Tadatsugu Morimoto
Mawatari Masaaki
Koji Ito
Takafumi Shimazaki
Publication date
08-07-2024
Publisher
Springer Nature Singapore
Published in
Journal of Bone and Mineral Metabolism
Print ISSN: 0914-8779
Electronic ISSN: 1435-5604
DOI
https://doi.org/10.1007/s00774-024-01531-5
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