Rouach Vanessa, Gortler Hilary, Greenman Yona, Chodick Gabriel, Goldshtein Inbal
Institute of Endocrinology, Diabetes, Hypertension and Metabolism, Sourasky Medical Center, Tel Aviv, Israel.
Epidemiology Department, School of Public Health, Gray School of Medecine, Tel Aviv University, Tel Aviv, Israel.
Front Endocrinol (Lausanne). 2025 Aug 4;16:1590472. doi: 10.3389/fendo.2025.1590472. eCollection 2025.
To assess the comparative effectiveness of zoledronic acid . denosumab in prevention of major osteoporotic fractures and mortality among patients with type 2 diabetes.
The study population was identified by crosslinking the diabetes and osteoporosis registries of a large healthcare organization in Israel. Demographics, Charlson Comorbidity Index (CCI), diabetes complications, bone mineral density (BMD) T-scores, hemoglobin A1c levels, eGFR, purchase of statins and anti-resorptive agents were collected. Exposure groups were matched using propensity score. Kaplan-Meier curves were generated to assess the time from treatment initiation to outcomes. Multivariable Cox's proportional hazards survival models estimated hazard ratios (HR) and 95% CIs for each outcome.
Among 27503 patients with concurrent osteoporosis and type 2 diabetes, 627 (4.7%) received zoledronic acid and 502 (3.7%) denosumab. Prior to matching, the denosumab-treated patients were older (mean age 75.7 71.9, p<0.01), had longer diabetes duration (mean 8.4 7.2 years, p<0.01), and had a lower baseline eGFR (59.4 75.3, p<0.01) than the zoledronic acid-treated patients. After matching, 415 pairs of subjects were included. The incidence of all examined outcomes was similar in the Zol and Dmab treatment groups, including 5-year cumulative incidence of fractures (38% 31%), death events (36% 41%), overall fracture risk (HR=1.17, 95% CI: 0.78 to 1.75), death risk (HR= 1.12, 95% CI:0.87 to 1.44), and mortality after a hip fracture (HR= 0.92, 95% CI:0.37-2.29).
Our findings suggest comparability of Zoledronic Acid and Denosumab in managing osteoporotic fractures and mortality among patients with type 2 diabetes.
评估唑来膦酸和地诺单抗在预防2型糖尿病患者严重骨质疏松性骨折及死亡方面的相对有效性。
通过将以色列一家大型医疗保健机构的糖尿病和骨质疏松症登记数据进行交叉比对来确定研究人群。收集人口统计学数据、Charlson合并症指数（CCI）、糖尿病并发症、骨密度（BMD）T值、糖化血红蛋白水平、估算肾小球滤过率（eGFR）、他汀类药物及抗吸收药物的购买情况。使用倾向评分对暴露组进行匹配。生成Kaplan-Meier曲线以评估从开始治疗到出现结局的时间。多变量Cox比例风险生存模型估计每个结局的风险比（HR）和95%置信区间（CI）。
在27503例同时患有骨质疏松症和2型糖尿病的患者中，627例（4.7%）接受了唑来膦酸治疗，502例（3.7%）接受了地诺单抗治疗。在匹配前，接受地诺单抗治疗的患者年龄更大（平均年龄75.7对71.9岁，p<0.01），糖尿病病程更长（平均8.4对7.2年，p<0.01），且基线eGFR更低（59.4对75.3，p<0.01），均低于接受唑来膦酸治疗的患者。匹配后，纳入了415对受试者。唑来膦酸组和地诺单抗治疗组所有检查结局的发生率相似，包括5年骨折累积发生率（38%对31%）、死亡事件（36%对41%）、总体骨折风险（HR=1.17，95%CI：0.78至1.75）、死亡风险（HR=1.12，95%CI：0.87至1.44）以及髋部骨折后的死亡率（HR=0.92，95%CI：0.37 - 2.29）。
我们的研究结果表明，唑来膦酸和地诺单抗在治疗2型糖尿病患者的骨质疏松性骨折及死亡方面具有可比性。
