文献类型：期刊文献

英文题名：Real-world pharmacovigilance of drug-induced osteoporosis: a focus on antiretroviral therapy and toxicological mechanisms in the elderly

作者：Liu, Xiaoyu[1];Gong, Yanlong[2];Liu, Lu[1];Wang, Xiaomin[1];Hu, Kangyi[1];Song, Min[1];Song, Yongjia[1]

第一作者：刘芯宇;刘熙钰;刘晓燕;刘翔毅

通信作者：Song, M[1];Song, YJ[1]

机构：[1]Gansu Univ Chinese Med, Clin Coll Chinese Med, Lanzhou, Gansu, Peoples R China;[2]Gansu Univ Chinese Med, Affiliated Hosp, Minimally Invas Spine Orthoped, Lanzhou, Gansu, Peoples R China

第一机构：甘肃中医药大学

通信机构：[1]corresponding author), Gansu Univ Chinese Med, Clin Coll Chinese Med, Lanzhou, Gansu, Peoples R China.|[10735]甘肃中医药大学;

年份：2026

卷号：17

外文期刊名：FRONTIERS IN PHARMACOLOGY

收录：;WOS:【SCI-EXPANDED(收录号:WOS:001744612200001)】；

基金：The author(s) declared that financial support was received for this work and/or its publication. The work was supported by 2024 Gansu Province University Teacher Innovation Fund Project (2024A-087). Science Research and Innovation Fund Project of Gansu University of Traditional Chinese Medicine in 2023 (2023KCZD-8). National Natural Science Foundation of China Regional Project (81960878).

语种：英文

外文关键词：decreased bone density; genderdifferences; induction time analysis; osteoporosis; pharmacovigilance analysis; toxicological analysis

摘要：Background Osteoporosis and bone density reduction are significant health concerns in elderly populations. While aging is a primary factor, drug-induced bone loss-particularly associated with antiviral agents, proton pump inhibitors (PPIs), and immunomodulatory drugs-has become a growing issue in patients managing multiple conditions.Objective This study aims to comprehensively assess adverse drug reactions (ADRs) related to bone density reduction and osteoporosis in elderly patients using the FDA Adverse Event Reporting System (FAERS). A specific focus is placed on HIV patients using antiretroviral therapy (ART), alongside an exploration of gender differences and toxicological mechanisms of high-risk drugs.Methods Data from FAERS (2004-Q2 2025) were analyzed using disproportionality analysis (DPA) to calculate Reporting Odds Ratios (RORs) and 95% confidence intervals (CIs). Toxicological analysis was conducted on high-risk drugs (e.g., Tenofovir Disoproxil) using PubChem, GeneCards, and GO/KEGG pathway enrichment to identify disrupted biological processes.Results Antiretroviral drugs exhibited the most significant risk signals. For decreased bone density, Emtricitabine/Tenofovir Disoproxil (ROR = 713.48, 95% CI: 648.66-784.79) and Tenofovir Disoproxil (ROR = 665.79, 95% CI: 611.91-724.42) showed extreme associations. For osteoporosis, significant signals were also identified for these antivirals, as well as for Esomeprazole (ROR = 12.23, 95% CI: 11.27-13.28) and Adalimumab (ROR = 2.16, 95% CI: 1.99-2.35). Gender-specific differences indicated men are at higher risk from antiviral drugs, whereas women are more affected by bone metabolic and immunomodulatory regulators. Toxicological analyses suggest these drugs disrupt vitamin D metabolism, calcium homeostasis, and parathyroid hormone (PTH) signaling.Conclusion Long-term use of antiretroviral drugs, PPIs, and immunomodulators is strongly linked to bone metabolic disorders in the elderly. Although pharmacovigilance studies utilizing FAERS are limited by spontaneous reporting bias and the inability to establish direct causality, these quantitative findings and toxicological insights provide robust real-world evidence for enhancing clinical monitoring and personalized risk management.