Bosco-Lévy Pauline, Briot Karine, Mehsen-Cetre Nadia, O'Kelly James, Désaméricq Gaëlle, Abouelfath Abdelilah, Lassalle Régis, Grelaud Angela, Grolleau Adeline, Blin Patrick, Droz-Perroteau Cécile
Bordeaux PharmacoEpi, INSERM CIC-P 1401 Université de Bordeaux Bordeaux France.
Service de rhumatologie Hôpital Cochin Paris France.
JBMR Plus. 2023 Jul 18;7(9):e10789. doi: 10.1002/jbm4.10789. eCollection 2023 Sep.
Although drugs for osteoporosis have been demonstrated to be effective in reducing fracture risk in placebo-controlled clinical trials, data on effectiveness in real-world practice is limited. Data from the French national health insurance claims database (SNDS) were used to follow five cohorts of women aged ≥55 years after initiating treatment for ≥6 months with either denosumab, zoledronic acid, oral bisphosphonates, raloxifene, or teriparatide in 2014-2016. Fracture incidence was compared within each cohort between the 3 months following initiation (baseline fracture risk) and the 12month, 18month, and 24 month postinitiation periods. Data are presented as incidence rate ratios (IRRs) with their 95% confidence intervals (CIs)s. Overall, 67,046 women were included in the denosumab cohort, 52,914 in the oral bisphosphonate cohort, 41,700 in the zoledronic acid cohort, 11,600 in the raloxifene cohort, and 7510 in the teriparatide cohort. The baseline vertebral fracture rate ranged from 1.74 per 1000 person years (‰PY) in the raloxifene cohort to 34.75‰PY in the teriparatide cohort, and the baseline hip fracture rate from 0.70‰PY in the raloxifene cohort to 10.52‰PY in the zoledronic acid cohort. Compared with the baseline fracture rate, vertebral fractures involving hospitalization were significantly reduced in the 3-24-month postinitiation period with denosumab (IRR 0.6; 95% CI, 0.5-0.7), zoledronic acid (IRR 0.4; 95% CI, 0.3-0.4), teriparatide (IRR 0.3; 95% CI, 0.2-0.5), and oral bisphosphonates (IRR 0.6; 95% CI, 0.4-0.8). Hip fracture incidence was reduced with denosumab (IRR 0.8; 95% CI, 0.6-0.9), but higher for oral bisphosphonates (IRR 1.7; 95% CI, 1.2-2.3); no significant change in hip fracture rate was observed for zoledronic acid, teriparatide, or raloxifene. A reduction in nonvertebral, non-hip fracture incidence was observed only in the denosumab cohort (IRR 0.8; 95% CI, 0.7-0.9). These findings indicate that treatment with osteoporosis drugs is effective in the real-world setting. © 2023 The Authors. published by Wiley Periodicals LLC on behalf of American Society for Bone and Mineral Research.
尽管在安慰剂对照临床试验中已证明治疗骨质疏松症的药物在降低骨折风险方面有效，但关于其在实际临床应用中的有效性数据有限。利用法国国家医疗保险索赔数据库（SNDS）的数据，对2014年至2016年开始使用地诺单抗、唑来膦酸、口服双膦酸盐、雷洛昔芬或特立帕肽治疗≥6个月的五组年龄≥55岁的女性进行随访。比较每组队列在开始治疗后的3个月（基线骨折风险）与开始治疗后的12个月、18个月和24个月期间的骨折发生率。数据以发病率比（IRR）及其95%置信区间（CI）表示。总体而言，地诺单抗队列纳入了67046名女性，口服双膦酸盐队列纳入了52914名女性，唑来膦酸队列纳入了41700名女性，雷洛昔芬队列纳入了11600名女性，特立帕肽队列纳入了7510名女性。基线椎体骨折率从雷洛昔芬队列中的每1000人年1.74例（‰PY）到特立帕肽队列中的34.75‰PY不等，基线髋部骨折率从雷洛昔芬队列中的0.70‰PY到唑来膦酸队列中的10.52‰PY不等。与基线骨折率相比，地诺单抗（IRR 0.6；95% CI，0.5 - 0.7）、唑来膦酸（IRR 0.4；95% CI，0.3 - 0.4）、特立帕肽（IRR 0.3；95% CI，0.2 - 0.5）和口服双膦酸盐（IRR 0.6；95% CI，0.4 - 0.8）在开始治疗后的3 - 24个月期间，涉及住院治疗的椎体骨折显著减少。地诺单抗可降低髋部骨折发生率（IRR 0.8；95% CI，0.6 - 0.9），但口服双膦酸盐的髋部骨折发生率更高（IRR 1.7；95% CI，1.2 - 2.3）；唑来膦酸、特立帕肽或雷洛昔芬的髋部骨折率未观察到显著变化。仅在地诺单抗队列中观察到非椎体、非髋部骨折发生率降低（IRR 0.8；95% CI，0.7 - 0.9）。这些发现表明，骨质疏松症药物治疗在实际临床应用中是有效的。© 2023作者。由Wiley Periodicals LLC代表美国骨与矿物质研究学会出版。
