Association Between Antiosteoporotic Drugs and Risk of Acute Kidney Injury: A Cross‐Sectional Study Using Disproportional Analysis and a Pharmacovigilance Database

Abstract The number of fractures related to osteoporosis is expected to increase. Therefore, clarifying the risk of acute kidney injury (AKI) associated with each type of antiosteoporotic drug may avoid discontinuation of osteoporosis pharmacotherapy due to onset of AKI. This cross‐sectional study using disproportional analysis and a pharmacovigilance database assessed the risk of AKI with various antiosteoporotic drugs by analyzing data entered into the US Food and Drug Administration's Adverse Event Reporting System from April 2014 to March 2021 and the Medical Data Vision database in Japan in November 2021. All antiosteoporotic drugs were investigated, including bisphosphonates, selective estrogen receptor modulators, denosumab, romosozumab, abaloparatide, and teriparatide. In the analysis of US Food and Drug Administration's Adverse Event Reporting System data, disproportionality for decreasing AKI was observed for oral ibandronate (reporting odds ratios [ROR], 0.22; 95%CI, 0.09‐0.45; P < .01), bazedoxifene (ROR, 0.26; 95%CI, 0.05‐0.77; P = .01), and intravenous ibandronate (ROR, 0.39; 95% CI, 0.14‐0.86; P = .01). In the analysis of the Medical Data Vision data, the incidence of AKI was lower in patients taking intravenous ibandronate (odds ratio, 0.22; 95%CI, 0.06‐0.89; P = .03), and the incidence of AKI was higher in patients taking oral alendronate (odds ratio, 2.40; 95%CI, 2.08‐2.77; P < .01). Risk of AKI may differ even among oral antiosteoporotic drugs, and the evidence of this association should be assessed further in future drug safety studies.