Hartz Martin C, Johannessen Fabian B, Harsløf Torben, Langdahl Bente L
Section for Bone Diseases, Department of Endocrinology, Aarhus University Hospital, 8200 Aarhus, Denmark.
J Clin Endocrinol Metab. 2025 Apr 22;110(5):e1640-e1652. doi: 10.1210/clinem/dgae484.
The purpose of this observational study was to investigate the effectiveness and safety of romosozumab (ROMO) and teriparatide (TPTD) in a clinical setting.
A total of 315 postmenopausal women were included based on the reimbursement criteria for ROMO and TPTD at the Department of Endocrinology at Aarhus University Hospital. Criteria for ROMO were bone mineral density (BMD) T-score < -2.5 (femoral neck [FN], total hip [TH], or lumbar spine [LS]) + a fragility fracture (hip, spine, pelvis, distal forearm, or proximal humerus) within 3 years. Criteria for TPTD: within 3 years, ≥ 2 vertebral fractures or 1 vertebral fracture + BMD T-score (FN, TH, or LS) < -3. Data were collected from medical records. The primary end point was percentage change from baseline in BMD (FN, TH, and LS) at month 12. BMD was measured by dual-energy x-ray absorptiometry (DXA).
At month 12, ROMO led to significantly (P < .001) larger increases than TPTD in BMD (FN: 4.8% vs 0.2%, TH: 5.7% vs 0.3%, and LS: 13.7% vs 9.3%). Discontinuation rate was lower with ROMO than with TPTD. Lower incidence of cardiovascular adverse events was observed with ROMO compared to TPTD. Treatment-naïve patients had nonsignificantly higher BMD increases compared to previously treated patients with both ROMO and TPTD.
Treatment with ROMO yields larger increases in BMD than TPTD after 12 months and a higher rate of completion. ROMO was associated with a higher adherence.
本观察性研究旨在调查罗莫单抗（ROMO）和特立帕肽（TPTD）在临床环境中的有效性和安全性。
根据奥胡斯大学医院内分泌科ROMO和TPTD的报销标准，共纳入315名绝经后女性。ROMO的标准为骨密度（BMD）T值< -2.5（股骨颈[FN]、全髋[TH]或腰椎[LS]）+ 3年内发生脆性骨折（髋部、脊柱、骨盆、远端前臂或近端肱骨）。TPTD的标准为：3年内≥2次椎体骨折或1次椎体骨折 + BMD T值（FN、TH或LS）< -3。数据从医疗记录中收集。主要终点是第12个月时BMD（FN、TH和LS）相对于基线的百分比变化。BMD通过双能X线吸收法（DXA）测量。
在第12个月时，ROMO导致BMD的增加显著大于TPTD（P <.001）（FN：4.8%对0.2%，TH：5.7%对0.3%，LS：13.7%对9.3%）。ROMO的停药率低于TPTD。与TPTD相比，ROMO观察到心血管不良事件的发生率更低。与既往接受过ROMO和TPTD治疗的患者相比，初治患者的BMD增加无显著更高。
ROMO治疗12个月后BMD的增加幅度大于TPTD，且完成率更高。ROMO的依从性更高。
