Amgen Ltd, Uxbridge, UK.
Amgen, Munich, Germany.
Arch Osteoporos. 2022 Aug 31;17(1):119. doi: 10.1007/s11657-022-01156-z.
This observational study assessed the impact on the fracture incidence of osteoporosis medications in postmenopausal women in Germany. Continued treatment with osteoporosis medications was associated with reductions of fracture rates in a real-world setting.
The efficacy of osteoporosis medications has been demonstrated in clinical trials, but a lack of evidence exists of their real-world effectiveness. This real-world study assessed the treatment patterns and impact on the fracture incidence of osteoporosis medications in postmenopausal women in Germany.
This cohort study used data from the WIG2 benchmark database, a German anonymised healthcare claims database. All women ≥ 50 years of age with ≥ 1 prescription for osteoporosis medication between 1 January 2013 and 31 December 2017 were included. The primary outcome was treatment effectiveness, evaluated as the change in fracture incidence after initiating treatment. Fracture types included all fractures, clinical vertebral, hip and wrist/forearm. Fracture incidence was assessed during the early-treatment period (0-3 months) and the on-treatment period (4-12, 13-24, 25-36 and 37-48 months).
Baseline covariates and treatment patterns were determined for 41,861 patients. The median duration of therapy was longer with denosumab (587 days) than with intravenous ibandronate (451 days), intravenous zoledronate (389 days) or oral bisphosphonates (258 days). The baseline incidence rate of all fractures was higher in patients receiving denosumab than in those receiving other treatments (87.6, 78.2, 56.6 and 66.0 per 1000 person-years for denosumab, oral bisphosphonates, intravenous ibandronate and intravenous zoledronate, respectively). Rates of all fractures declined with continued denosumab (by 38%, 50%, 56% and 67% at 12, 24, 36 and 48 months, respectively) and oral bisphosphonates (by 39%, 44%, 49% and 42%, respectively) treatment.
Continued treatment with osteoporosis medications was associated with reductions of fracture rates in a real-world setting.
本观察性研究评估了骨质疏松症药物对德国绝经后妇女骨折发生率的影响。在真实世界环境中，继续骨质疏松症药物治疗与降低骨折率相关。
本队列研究使用了德国匿名医疗索赔数据库 WIG2 基准数据库的数据。纳入了 2013 年 1 月 1 日至 2017 年 12 月 31 日期间至少有 1 份骨质疏松症药物处方的≥50 岁的所有女性。主要结局是治疗效果，评估为起始治疗后骨折发生率的变化。骨折类型包括所有骨折、临床椎体、髋部和腕部/前臂骨折。骨折发生率在早期治疗期（0-3 个月）和治疗期（4-12、13-24、25-36 和 37-48 个月）进行评估。
确定了 41861 例患者的基线协变量和治疗模式。地舒单抗（587 天）的中位治疗持续时间长于静脉用伊班膦酸盐（451 天）、静脉用唑来膦酸（389 天）或口服双膦酸盐（258 天）。接受地舒单抗治疗的患者的所有骨折基线发生率高于接受其他治疗的患者（地舒单抗、口服双膦酸盐、静脉用伊班膦酸盐和静脉用唑来膦酸的发生率分别为 87.6、78.2、56.6 和 66.0/1000 人年）。随着地舒单抗（12、24、36 和 48 个月时分别下降 38%、50%、56%和 67%）和口服双膦酸盐（12、24、36 和 48 个月时分别下降 39%、44%、49%和 42%）治疗的持续，所有骨折的发生率均下降。
在真实世界环境中，继续骨质疏松症药物治疗与降低骨折率相关。
