Effects of denosumab or romosozumab on vascular calcification in dialysis patients: a systematic review and meta-analysis.

Abstract

Introduction: Patients on hemodialysis are at high risk of vascular calcification, which contributes to cardiovascular events and mortality. The impact of osteoporosis therapies, including denosumab and romosozumab, on vascular calcification in this population remains uncertain. This systematic review and meta-analysis aim to synthesize current evidence on their effects, addressing a critical knowledge gap in advanced chronic kidney disease (CKD) management.

Methods: MEDLINE, Embase, and Web of Science were searched through November 2025 for studies evaluating either denosumab or romosozumab and vascular calcification in hemodialysis patients. Random-effects models were used to pool standardized mean differences (SMDs) with 95% confidence intervals, and leave-one-out sensitivity analyses assessed robustness.

Results: Six studies on denosumab and one on romosozumab were included. Meta-analysis of denosumab (422 participants) showed a small, non-significant change in vascular calcification (SMD -0.20 95% CI -0.75 to 0.36; I² = 82.6%). Subgroup analysis of coronary artery calcification yielded similar non-significant results (SMD -0.22, 95% CI -0.67 to 0.23; I² = 41.5%). The single romosozumab study reported a significant increase in calcium score from baseline. All studies reported post-injection hypocalcemia.

Conclusion: Current evidence indicates that denosumab does not significantly alter vascular calcification in dialysis patients, whereas limited data suggest romosozumab may increase vascular calcification. Serum calcium should be monitored in dialysis patients receiving these agents. Given the small number of studies and substantial heterogeneity, further well-designed prospective studies are required to clarify the cardiovascular safety of these agents in advanced CKD.