Denosumab use is not restricted to individuals with osteoporosis who have advanced kidney disease. However, concerns remain regarding the risk of severe hypocalcemia in such patients.
In a cohort study of 2804 female patients (aged ≥65 years) with osteoporosis and undergoing dialysis, severe hypocalcemia (serum calcium <7.5 mg/dL [1.9 mmol/L] or hypocalcemia requiring emergency care) occurred in a higher proportion of patients who initiated denosumab compared with those who initiated an oral bisphosphonate (12-week weighted cumulative incidence 41.1 versus 2 percent, respectively) [1]. Denosumab also was associated with a higher incidence of very severe hypocalcemia (serum calcium <6.5 mg/dL [1.6 mmol/L]).
A boxed warning about the risk of severe hypocalcemia in individuals with advanced kidney disease, especially patients on dialysis, has been added for the brand name denosumab (Prolia) [2], underscoring the need for greater caution and increased monitoring during treatment.
Reference
- Bird ST, Smith ER, Gelperin K, et al. Severe Hypocalcemia With Denosumab Among Older Female Dialysis-Dependent Patients. JAMA 2024.
- FDA drug safety communication for Prolia. Available at: https://www.fda.gov/media/175509/download?attachment (Accessed on January 22, 2024).
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