Real-world pharmacovigilance of drug-related bone metabolism disorders: integrating FAERS and VigiAccess with a Bradford Hill-based causal plausibility assessment

BackgroundMetabolic bone diseases (MBDs) are a group of conditions characterized by imbalanced bone remodeling, including osteoporosis, osteomalacia, and rickets. In recent years, drug-induced secondary MBDs have emerged as a major clinical concern. However, systematic drug risk assessment studies based on large-scale real-world data remain scarce.MethodsBased on the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS, 2004–2024) and VigiAccess, four complementary disproporti