Department of Medical Research, Pharmaserve Lilly, 15th Km National Road Athens-Lamia, Kifissia, Greece.
Papageorgiou General Hospital, 3rd Orthopedics University Clinic, Thessaloniki, Greece.
Hormones (Athens). 2018 Dec;17(4):531-540. doi: 10.1007/s42000-018-0077-6. Epub 2018 Nov 14.
We present the subanalysis of the Greek cohort of the Extended Forsteo Observational Study (ExFOS), a multicenter, non-interventional, prospective, observational study evaluating the effect of teriparatide on fractures, back pain (BP), health-related quality of life (HR-QoL), and safety and compliance, in patients with osteoporosis treated for up to 24 months, with a post-treatment follow-up of at least 18 months.
A total of 439 osteoporotic patients (92.2% female) were enrolled in Greece. New or worsened fractures, based on their physicians' assessment, as well as patients' self-assessment of HR-QoL and BP, compliance, and safety profile, were captured by validated questionnaires.
In the ExFOS Greek cohort, fracture rates were low and mean bone mineral density (BMD) was numerically improved. Compliance with teriparatide remained high throughout the study, with 81.5% of subjects completing treatment. Only 0.7% of patients reported discontinuation due to adverse effects. A sustainable improvement in patient-perceived BP and HRQoL throughout treatment and follow-up was similar to that achieved by the European Forsteo Observational Study (EFOS). A lower than expected percentage of patients using antiresorptives following teriparatide was recorded.
ExFOS reproduces the outcomes of EFOS, with a 6.5-year time interval between studies, in comparable cohorts of osteoporotic patients. Data should be interpreted in the context of observational study data collection, although summary statistics computed at each time point may overstate drug effect.
我们呈现了希腊队列的扩展福司妥观察研究（ExFOS）的亚组分析，这是一项多中心、非干预性、前瞻性、观察性研究，评估特立帕肽对骨折、背痛（BP）、健康相关生活质量（HR-QoL）的影响，以及安全性和依从性，在接受骨质疏松症治疗长达 24 个月的患者中，在治疗后至少 18 个月的随访。
总共招募了 439 名骨质疏松症患者（92.2%为女性）。新的或恶化的骨折，基于他们的医生的评估，以及患者的自我评估的 HR-QoL 和 BP、依从性和安全性概况，通过验证问卷捕获。
在 ExFOS 希腊队列中，骨折率较低，平均骨密度（BMD）数值有所改善。特立帕肽的依从性在整个研究中保持较高水平，81.5%的患者完成了治疗。只有 0.7%的患者因不良反应而报告停药。在治疗和随访过程中，患者感知的 BP 和 HRQoL 持续改善，与欧洲福司妥观察研究（EFOS）相似。记录到使用抗吸收剂治疗特立帕肽后，患者的比例低于预期。
ExFOS 在 6.5 年的研究间隔时间内，复制了 EFOS 的结果，在可比的骨质疏松患者队列中。数据应在观察性研究数据收集的背景下进行解释，尽管在每个时间点计算的汇总统计数据可能夸大了药物的效果。
