Department of Endocrinology, Endocrinology Research Center, Xiangya Hospital of Central South University, Changsha, 410008, Hunan, China.
Department of Gastroenterology, Xiangya Hospital of Central South University, Changsha, 410008, Hunan, China.
Sci Rep. 2023 Jul 5;13(1):10892. doi: 10.1038/s41598-023-37944-x.
Atypical femur fracture (AFF) is a rare but catastrophic adverse event first reported in the long-term use of alendronate, one of the most commonly used drugs for osteoporosis currently. However, further evidence is needed to learn more regarding other common anti-osteoporosis drugs and the risk for AFF. In this study, reports of AFF were identified from Food and Drug Administration Adverse Event Reporting System database. Disproportionality analyses were performed to examine the reporting odds ratio (ROR), information component (IC) and adjusted ROR (adj. ROR) signals for AFF for common anti-osteoporosis drugs. A total of 1692 unique AFF reports were identified. The disproportionality signals (the lower bound of 95% confidence interval > 1 for ROR and adjusted ROR, and > 0 for IC) were detected for alendronate, denosumab, pamidronate, risedronate, zoledronate, ibandronate, and teriparatide while no signal was detected for raloxifene, abaloparatide, and romosozumab. When restricted in patients with osteoporosis, the disproportionality signals were still detected for alendronate, pamidronate, risedronate, denosumab, and ibandronate. Our results suggest that alendronate has the largest risk signal, while the risks varied among different bisphosphonates. In addition, denosumab was found statistically associated with AFF in both the entire database and patients with osteoporosis.
非典型股骨骨折（AFF）是一种罕见但灾难性的不良事件，最初在长期使用阿仑膦酸钠（目前最常用的骨质疏松症药物之一）时报告。然而，需要进一步的证据来了解其他常用抗骨质疏松症药物和 AFF 的风险。在这项研究中，从美国食品和药物管理局不良事件报告系统数据库中确定了 AFF 的报告。进行了不相称性分析，以检查 AFF 常见抗骨质疏松症药物的报告比值比（ROR）、信息成分（IC）和调整后的 ROR（adj. ROR）信号。共确定了 1692 份独特的 AFF 报告。不相称性信号（ROR 和 adj. ROR 的 95%置信区间下限 > 1，IC 的下限 > 0）被检测到用于阿仑膦酸钠、地舒单抗、帕米膦酸、利塞膦酸钠、唑来膦酸、伊班膦酸和特立帕肽，而雷洛昔芬、abaloparatide 和 romosozumab 则未检测到信号。当仅限于骨质疏松症患者时，仍检测到阿仑膦酸钠、帕米膦酸、利塞膦酸钠、地舒单抗和伊班膦酸的不相称性信号。我们的结果表明，阿仑膦酸钠的风险信号最大，而不同双膦酸盐之间的风险存在差异。此外，在整个数据库和骨质疏松症患者中，地舒单抗都被发现与 AFF 存在统计学关联。
