Characterization of patients in the European Forsteo Observational Study (EFOS): postmenopausal women entering teriparatide treatment in a community setting

Characterization of patients in the European Forsteo Observational Study (EFOS): postmenopausal women entering teriparatide treatment in a community setting
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DOI:
10.1185/030079908x261087
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发表时间:
2008-02-01
影响因子:
2.3
通讯作者:
Marin, Fernando
Marin, Fernando
中科院分区:
医学4区
文献类型:
--
作者:
Rajzbaum, Gerald;Jakob, Franz;Marin, Fernando

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目的:欧洲Forsteo* 观察性研究(EFOS)研究主要旨在评估社区环境中特立哌齐处方女性的骨折发生率、疼痛程度、健康相关生活质量(HRQoL)和依从性。本报告介绍了设计的研究和特点的患者在entry.Methods:在进入,1645绝经后妇女诊断为骨质疏松症,即将启动teriparbazole治疗在8个欧洲国家。基线数据收集的人口统计学特征,医疗和骨质疏松症的历史,疾病状态,以前使用的药物和HRQoL。平均(标准差[SDI])患者年龄为71.5 8.4岁时,腰椎骨密度(BMD)T评分为-3.3(1.2),40岁后报告的既往骨折平均数为2.9(2.0),70%有两个或两个以上椎体畸形,91.7%接受双膦酸盐预治疗。通过欧洲生活质量问卷(EQ-5D)的健康状态值(HSV)(中位数:0.59,Q1; Q3:0.08; 0.71)和视觉模拟量表(VAS)(中位数:50.0,Q1; Q3:35.0; 69.0)评估的HRQoL状态较差。31%的患者报告了疼痛/不适维度的极端问题,69%的患者活动受限,57%的患者报告了焦虑/抑郁。慢性或间歇性背痛的患者,发生在每天或几乎每天在最后一个month. Conclusions 66%的patients.Conclusions:绝经后妇女规定teriparterine严重骨质疏松症,骨折风险高,HRQoL差,尽管以前的治疗骨质疏松症。中度至重度背痛非常常见。
Objective: The European Forsteo* Observational Study (EFOS) study was primarily designed to assess fracture incidence, degree of pain, health-related quality of life (HRQoL) and compliance in women prescribed teriparatide in a community setting. This report describes the design of the study and characteristics of the patients at entry.Methods: At entry, 1645 postmenopausal women with a diagnosis of osteoporosis and about to initiate teriparatide treatment were enrolled in eight European countries. Baseline data were collected on demographic characteristics, medical and osteoporosis history, disease status, prior use of medications and HRQoL.Results: The mean (standard deviation [SDI) age of patients was 71.5 (8.4) years, lumbar spine bone mineral density (BMD) T-score was -3.3 (1.2), the mean number of previous fractures reported after 40 years of age was 2.9 (2.0), 70% had two or more vertebral deformities and 91.7% were pre-treated with bisphosphonates. HRQoL, evaluated by the health state value (HSV) (median: 0.59, Q1; Q3: 0.08; 0.71) and visual analogue scale (VAS) (median 50.0, Q1; Q3: 35.0; 69.0) status of the European quality of life questionnaire (EQ-5D) was poor. Extreme problems were reported by 31% of patients for the pain/discomfort dimension, mobility was limited in 69% and anxiety/depression was reported by 57% of patients. Chronic or intermittent back pain was reported by 91% of patients, which occurred every day or almost every day within the last month in 66% of patients.Conclusions: The post-menopausal women prescribed teriparatide were severely osteoporotic, with a high fracture risk and poor HRQoL, despite previous therapy for osteoporosis. Moderate to severe back pain was very common.