Denosumab safety in men with osteoporosis: a disproportionality analysis of the FAERS database

This study aims to assess the spectrum of adverse events (AEs) associated with denosumab using in male patients with osteoporosis, leveraging the FDA Adverse Event Reporting System (FAERS) database from the Q3 2010 to Q4 2024. Four disproportionality analysis methods-reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN), and empirical Bayesian geometric mean (EBGM) were applied to detect denosumab-associated AEs. Clinical priority was assigned to signals by scoring five features using a rating scale. Among 3370 AEs associated with denosumab in male osteoporosis patients, general disorders and administration site conditions, skin and subcutaneous tissue disorders, and metabolism and nutrition disorders showed positive signals at the system organ class (SOCs) level. At the preferred term (PT) level, the most frequently reported AEs included back pain, arthralgia, osteonecrosis of jaw, and hypocalcemia. Notably, a comparative analysis with female patients delineated a distinct male-specific safety profile, characterized by stronger signal intensity for AEs such as hypocalcemia, pain in extremity, pneumonia, increased blood parathyroid hormone, and chronic obstructive pulmonary disease. This study comprehensively characterizes the safety profile of denosumab in male osteoporosis patients revealing distinct gender-specific adverse event patterns, providing a critical reference for optimizing pharmacotherapy and clinical monitoring for male patients with osteoporosis.