Key result
Romosozumab shows no difference in cardiovascular mortality or major events versus placebo.
Why the study?
Does romosozumab increase cardiovascular mortality or major cardiovascular events compared to alendronate, teriparatide, denosumab, or placebo in postmenopausal women with osteoporosis?
Meta-Analysis (n=24,942)
Does romosozumab increase cardiovascular mortality or major cardiovascular events compared to alendronate, teriparatide, denosumab, or placebo in postmenopausal women with osteoporosis?
Romosozumab appears to have a safe cardiovascular profile in postmenopausal women with osteoporosis, with no significant increase in cardiovascular mortality or major adverse cardiovascular events compared to placebo.
INTRODUCTION: The aim of this study was to investigate the cardiovascular safety of romosozumab in postmenopausal women with osteoporosis. Romosozumab, a monoclonal antibody targeting sclerostin, has been shown to increase bone mineral density and reduce the risk of osteoporotic fractures. However, in previous studies, romosozumab therapy was identified as a potential risk factor for cardiovascular events, particularly in patients with predisposing cardiovascular disease. METHODS: A systematic literature search was performed in the Cochrane Library, Embase, PubMed, and Web of Science databases to identify randomized controlled trials (RCTs) comparing the safety and efficacy of romosozumab versus alendronate, teriparatide, denosumab, or placebo in postmenopausal women with osteoporosis. Contrast-based network meta-analysis was performed using a random-effects model. The pooled estimates are presented as risk ratios with 95% confidence intervals. RESULTS: Of the 5282 articles retrieved, 25 RCTs were included in this review (n = 24,942), and 18 randomized controlled trials (n = 16,777) were included in the network meta-analysis. The results indicated no significant differences in cardiovascular mortality rate between romosozumab and placebo. Regarding the risk of major cardiovascular events, no significant differences were found in the direct evidence or the network meta-analysis with placebo as the reference. CONCLUSION: Romosozumab might be a safe option for treating postmenopausal women with osteoporosis. The cardiovascular concerns associated with this treatment seem less significant than previously suggested, although additional real-world data are required to confirm this conclusion.
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Cheng et al. (2024) conducted a meta-analysis in postmenopausal osteoporosis (n=24,942). Romosozumab vs. alendronate, teriparatide, denosumab, or placebo was evaluated on Cardiovascular mortality rate and risk of major cardiovascular events. Romosozumab showed no significant differences in cardiovascular mortality or major cardiovascular events compared to placebo in postmenopausal women with osteoporosis.
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