Dialysis patients treated with denosumab (Prolia, Xgeva) had a lower risk of fractures but a higher risk of certain heart events, according to an observational trial designed to emulate a clinical trial.
Among 1,032 Japanese dialysis patients who initiated treatment for osteoporosis, denosumab use was associated with a 45% lower risk for all fractures (RR 0.55, 95% CI 0.28-0.93) compared to oral bisphosphonates over three years. However, denosumab users also showed a trend toward a 36% higher risk of major adverse cardiovascular events (MACE), though this finding was not statistically significant (RR 1.36, 95% CI 0.99-1.87).
Lead study author Dr. Soichiro Masuda noted that while the benefit of fracture prevention was significant, cardiovascular risks warrant further investigation. Bisphosphonates remain the first-line treatment for preventing fractures in osteoporosis, though they must be used cautiously in patients with chronic kidney disease.
In January 2024, the FDA added a boxed warning to denosumab’s label regarding the risk of severe hypocalcemia in patients with advanced kidney disease. For this reason, clinicians are advised to carefully select appropriate patients and monitor blood calcium levels closely.
The study, published in Annals of Internal Medicine, highlighted the need for large-scale prospective studies to confirm these findings and further explore the risks and benefits of denosumab compared to bisphosphonates in this population.
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