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Effectiveness of Teriparatide in Women Over 75 Years of Age with Severe Osteoporosis: 36-Month Results from the European Forsteo Observational Study (EFOS)

机译:特立帕肽对75岁以上严重骨质疏松症妇女的有效性:欧洲Forsteo观察研究(EFOS)的36个月结果

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摘要

This predefined analysis of the European Forsteo Observational Study (EFOS) aimed to describe clinical fracture incidence, back pain, and health-related quality of life (HRQoL) during 18 months of teriparatide treatment and 18 months post-teriparatide in the subgroup of 589 postmenopausal women with osteoporosis aged ≥75 years. Data on clinical fractures, back pain (visual analogue scale, VAS), and HRQoL (EQ-5D) were collected over 36 months. Fracture data were summarized in 6-month intervals and analyzed using logistic regression with repeated measures. A repeated-measures model analyzed changes from baseline in back pain VAS and EQ-VAS. During the 36-month observation period, 87 (14.8 %) women aged ≥75 years sustained a total of 111 new fractures: 37 (33.3 %) vertebral fractures and 74 (66.7 %) nonvertebral fractures. Adjusted odds of fracture was decreased by 80 % in the 30 to <36–month interval compared with the first 6-month interval (P < 0.009). Although the older subgroup had higher back pain scores and poorer HRQoL at baseline than the younger subgroup, both age groups showed significant reductions in back pain and improvements in HRQoL postbaseline. In conclusion, women aged ≥75 years with severe postmenopausal osteoporosis treated with teriparatide in normal clinical practice showed a reduced clinical fracture incidence by 30 months compared with baseline. An improvement in HRQoL and, possibly, an early and significant reduction in back pain were also observed, which lasted for at least 18 months after teriparatide discontinuation when patients were taking other osteoporosis medication. The results should be interpreted in the context of an uncontrolled observational study.
机译:这项对欧洲Forsteo观察性研究(EFOS)的预定义分析旨在描述绝经后589个亚组特立帕肽治疗18个月和特立帕肽治疗18个月后的临床骨折发生率,背痛和健康相关的生活质量(HRQoL)。骨质疏松症的女性年龄≥75岁。在36个月内收集了有关临床骨折,背痛(视觉模拟评分,VAS)和HRQoL(EQ-5D)的数据。骨折数据以6个月为间隔进行汇总,并使用Logistic回归和重复测量进行分析。重复测量模型分析了背痛VAS和EQ-VAS与基线相比的变化。在36个月的观察期内,年龄≥75岁的87名(14.8%)妇女共发生111例新骨折:37例(33.3%)椎骨骨折和74例(66.7%)非椎骨骨折。与前6个月的间隔相比,在30个月至<36个月的间隔内,调整后的骨折几率降低了80%(P <0.009)。尽管年龄较大的亚组在基线时的背痛评分较高,HRQoL较年轻的亚组低,但两个年龄组均显示出明显的背痛减轻和基线后HRQoL改善。总之,在正常临床实践中,特立帕肽治疗的≥75岁严重绝经后骨质疏松症的妇女与基线相比,临床骨折发生率降低了30个月。还观察到HRQoL的改善,并且可能还可以显着减轻背部疼痛,当患者服用其他骨质疏松症药物时,终止特立帕肽治疗后至少持续18个月。应在不受控制的观察研究的背景下解释结果。

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