Study description and baseline characteristics of the population enrolled in a multinational observational study of extended teriparatide use (ExFOS)
Study description and baseline characteristics of the population enrolled in a multinational observational study of extended teriparatide use (ExFOS)
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DOI：
10.1185/03007995.2014.907561
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发表时间：
2014-08-01
影响因子：
2.3
通讯作者：
Lindh, E.
中科院分区：
文献类型：
--
作者：
Ljunggren, O.;Benhamou, C. L.;Lindh, E.
目的：为了更好地描述欧洲目前正在服用特立帕肽的患者，本文描述了扩展Forsteo*观察性研究（ExFOS）参与者的研究设计和基线特征。研究设计和方法：ExFOS是一项非介入性、多中心、前瞻性、观察性研究，在正常临床实践过程中接受特立帕肽治疗的骨质疏松症男性和女性，治疗后随访至少18个月。主要结局指标：基线特征，包括骨折和背痛史，以及与健康相关的生活质量（HRQoL，使用EuroQol-5维度[EQ-5D]评估）。结果：入组的1607例患者中，90.9%为女性。基线时，平均（标准差[SD]）年龄为70.3（9.8）岁，85.8%的患者有骨折史（其中64.7%为>= 2脆性骨折）。在有骨折史的患者中，90.8%有椎体骨折（67.8%有胸椎骨折）。腰椎、全髋关节（左）和股骨颈（左）报告的骨密度t评分的平均值（SD）分别为-3.0（1.2）、-2.4（1.0）和-2.5（0.9）。总体而言，在入组前的12个月内，39.3%的患者经历了>= 1的下降。基线时，11.4%的患者未接受骨质疏松治疗，15%的患者目前正在使用糖皮质激素。上个月背痛的平均（SD）视觉模拟量表评分为50.7(26.9)，62.1%的患者每天或几乎每天都有背痛。基线时EQ-5D健康状态值中位数为0.62（第一和第三四分位数：0.19,0.74）。结论：ExFOS研究队列的基线特征表明，欧洲服用特立帕肽的患者有严重的骨质疏松症，椎体骨折高度普遍，背部疼痛频繁且致残性，HRQoL较差，尽管先前有骨质疏松症的药物治疗。局限性包括非随机分组，缺乏比较组，患者自我报告既往用药和骨折史数据。
Objective:To better characterize patients who are currently being prescribed teriparatide in Europe, this article describes the study design and baseline characteristics of participants of the Extended Forsteo* Observational Study (ExFOS).Research design and methods:ExFOS is a noninterventional, multicenter, prospective, observational study in men and women with osteoporosis treated with teriparatide during the course of normal clinical practice for up to 24 months and with a post-treatment follow-up of at least 18 months.Main outcome measures:Baseline characteristics, including history of fracture and back pain, and health-related quality of life (HRQoL, assessed using the EuroQol-5 Dimension [EQ-5D]).Results:Of 1607 patients enrolled, 90.9% were women. At baseline, mean (standard deviation [SD]) age was 70.3 (9.8) years, and 85.8% of patients had a history of fracture (64.7% with >= 2 fragility fractures). Of those with historic fractures, 90.8% had vertebral fractures (67.8% had thoracic fractures). The mean (SD) of reported bone mineral density T-scores were -3.0 (1.2), -2.4 (1.0), and -2.5 (0.9) for lumbar spine, total hip (left), and femoral neck (left), respectively. Overall, 39.3% of patients had experienced >= 1 fall during the 12 months before enrollment. At baseline, 11.4% of patients were osteoporosis-treatment naive and 15% were currently using glucocorticoids. The mean (SD) visual analog scale score for back pain during the last month was 50.7 (26.9), and 62.1% of patients experienced daily or almost daily back pain. The median EQ-5D health state value at baseline was 0.62 (first and third quartiles: 0.19, 0.74).Conclusions:Baseline characteristics of the ExFOS study cohort indicate that patients prescribed teriparatide in Europe have severe osteoporosis with highly prevalent vertebral fractures, frequent and disabling back pain, and a poor HRQoL, despite previous pharmacotherapy for osteoporosis. Limitations include non-randomization, lack of a comparator group, and patient self-report for data on prior medication and fracture history.