Persson Rebecca, Hagberg Katrina Wilcox, Pranschke Emma, Vasilakis-Scaramozza Catherine, Jick Susan
BCDSP, Boston Collaborative Drug Surveillance Program, Lexington, MA, USA.
Department of Epidemiology, Boston University School of Public Health, Boston, MA, USA.
Osteoporos Int. 2025 Jan;36(1):47-60. doi: 10.1007/s00198-024-07262-7. Epub 2024 Oct 14.
Osteonecrosis of the jaw (ONJ) is an adverse effect of antiresorptives. Among female patients treated for osteoporosis, ONJ risk was threefold higher after 2-3 years of treatment and eightfold after 10 years compared with past use. Absolute risks remained low (~ 0.05% after 5 years) and diminished after discontinuation.
Osteonecrosis of the jaw (ONJ) is a rare adverse effect of antiresorptive drug use; however, the magnitude of risk in osteoporosis patients has not been clearly described.
We conducted a cohort study among cancer-free female patients aged 40-89 with, or at risk for, osteoporosis in United Kingdom Clinical Practice Research Datalink (CPRD) Aurum. We followed patients from first osteoporosis treatment until first of osteonecrosis diagnosis, age 90, record end, or other prespecified censoring event, and accumulated person-time by osteoporosis treatment. ONJ cases were selected from CPRD Aurum and linked Hospital Episode Statistics data using an algorithm and manual review. We estimated incidence rates (IR) of ONJ by current treatment type and post discontinuation. We conducted a nested case-control analysis to further describe risk by cumulative dose and duration of antiresorptive therapies.
Among 467,654 eligible patients, there were 208 ONJ cases. IR among patients currently treated with antiresorptives (primarily alendronate) was 1.2 (95% confidence interval [CI] 1.0-1.4) per 10,000 person-years. Compared with past use of antiresorptives, odds ratios of ONJ were 3.0 (95% CI 1.5-5.7) after 2-3 years of treatment and 8.1 (95% CI 4.4-15) after 10 years. However, absolute risks remained low (~ 0.05% after 5 years and ~ 0.18% after 10 years) and elevated risks diminished to near zero within 6 to 9 months of discontinuation.
Risk of ONJ increased after 2-3 years of treatment with antiresorptives; however, the absolute risk was low and returned to baseline shortly after treatment discontinuation.
颌骨坏死（ONJ）是抗骨吸收药物的一种不良反应。在接受骨质疏松症治疗的女性患者中，治疗2 - 3年后ONJ风险是过去用药时的3倍，10年后是8倍。绝对风险仍然较低（5年后约为0.05%），停药后风险降低。
颌骨坏死（ONJ）是抗骨吸收药物使用中一种罕见的不良反应；然而，骨质疏松症患者的风险程度尚未得到明确描述。
我们在英国临床实践研究数据链（CPRD）奥鲁姆中对40 - 89岁无癌症、患有或有骨质疏松症风险的女性患者进行了一项队列研究。我们追踪患者从首次骨质疏松症治疗到首次诊断为骨坏死、年满90岁、记录结束或其他预先指定的审查事件，并按骨质疏松症治疗累积人时。ONJ病例从CPRD奥鲁姆中选取，并使用算法和人工审查与医院事件统计数据相关联。我们按当前治疗类型和停药后估计ONJ的发病率（IR）。我们进行了一项巢式病例对照分析，以进一步按抗骨吸收治疗的累积剂量和持续时间描述风险。
在467,654名符合条件的患者中，有208例ONJ病例。目前接受抗骨吸收药物（主要是阿仑膦酸盐）治疗的患者中，IR为每10,000人年1.2（95%置信区间[CI]1.0 - 1.4）。与过去使用抗骨吸收药物相比，治疗2 - 3年后ONJ的比值比为3.0（95%CI 1.5 - 5.7），10年后为8.1（95%CI 4.4 - 15）。然而，绝对风险仍然较低（5年后约为0.05%，10年后约为0.18%），停药后6至9个月内升高的风险降至接近零。
抗骨吸收药物治疗2 - 3年后ONJ风险增加；然而，绝对风险较低，停药后不久即恢复到基线水平。
