魏正宗WEI, CHENG-CHUNG洪正憲HUNG, CHENG-HSIENCHENG-HSIENHUNG醫學研究所碩士班2026-10-292026-06-3020262026-06-18https://handle.ncl.edu.tw/11296/t6q6fzhttps://scholars.csmu.edu.tw/handle/123456789/36767研究目的：骨質疏鬆症常與慢性腎臟病 (chronic kidney disease, CKD) 共存，會增加骨骼的脆弱性以及心血管疾病的風險。雖然romosozumab在治療一般骨質疏鬆症方面表現良好，但在慢性腎臟病第 3 至 5 期患者中的療效仍缺乏足夠的證據支持。研究方法及資料：本研究採用目標試驗模擬 (target trial emulation) 設計，利用 TriNetX 美國研究網絡進行回顧性世代研究。研究對象為年齡在 40 歲以上、患有骨質疏鬆症，且估計腎絲球過濾率 (eGFR) 低於 60 mL/min/1.73 m² 的受試者。在進行 1:1 傾向分數匹配 (propensity score matching, PSM) 後，以 Cox 比例風險模型評估研究結果。主要療效指標為 12 個月內的非脊椎及脊椎骨折；次要指標為髖部骨折。安全性指標包括主要不良心血管事件 (MACE)、心肌梗塞 (MI)、中風以及全因死亡。結果：經 PSM 後，每組各納入 2,045 名患者。與teriparatide相比，romosozumab能顯著降低脊椎骨折的風險（HR, 0.64；95% CI, 0.42–0.98）；對於非脊椎骨折或髖部骨折則無顯著差異。在心血管安全方面，romosozumab能降低 MACE（HR, 0.82；95% CI, 0.70–0.97）與心肌梗塞（HR, 0.77；95% CI, 0.63–0.95）的風險。這些結果在多數子群與敏感度分析中保持一致。結論與建議：在患有骨質疏鬆症與慢性腎臟病的患者中，romosozumab在降低脊椎骨折風險方面較teriparatide更有效，同時也能降低重大心血管事件的發生率。這些結果支持romosozumab對此高風險族群的雙重益處，並凸顯進一步前瞻性研究的必要性，尤其是針對晚期慢性腎臟病患者。Background: Osteoporosis commonly coexists with chronic kidney disease (CKD), increasing skeletal fragility and cardiovascular risk. While romosozumab shows superior fracture prevention in general osteoporosis, evidence in CKD stages 3–5 patients remains limited.Methods: Using a target trial emulation design, we conducted a retrospective cohort study leveraging the TriNetX U.S. research network. Patients aged ≥40 years with osteoporosis and an estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m² were included. After 1:1 propensity score matching (PSM), outcomes were assessed using Cox proportional hazards models. The primary effectiveness outcomes were non-vertebral and vertebral fractures within 12 months. The secondary outcome was hip fractures. Safety outcomes included MACE, myocardial infarction (MI), stroke, and all-cause mortality.Results: After PSM, 2,045 patients were included in each group. Romosozumab was associated with a significantly lower risk of vertebral fractures compared with teriparatide (HR, 0.64; 95% CI, 0.42–0.98), whereas no significant differences were observed for non-vertebral or hip fractures. Romosozumab was linked to a reduced risk of MACE (HR, 0.82; 95% CI, 0.70–0.97) and MI (HR, 0.77; 95% CI, 0.63–0.95). These findings were generally consistent across most subgroups and sensitivity analyses.Conclusion: In patients with osteoporosis and CKD, romosozumab was more effective than teriparatide in reducing vertebral fracture risk and was associated with a lower incidence of major cardiovascular events. These findings support the potential dual benefits of romosozumab in this high-risk population and highlight the need for further prospective studies, particularly in those with advanced CKD.RomosozumabTeriparatide骨質疏鬆症慢性腎臟病骨折心血管安全性OsteoporosisChronic Kidney DiseaseFractureCardiovascular Safetythesis