NCT00478569已完成不适用
Adherence to PTH(1-84) Treatment in Europe. A Non-interventional Cohort Study Collecting Safety Information and Examining Reasons and Predictors for Adherence to PTH(1-84) Treatment in Usual Clinical Settings
Takeda1 个研究点 分布在 1 个国家目标入组 1,179 人开始时间: 2007年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,179
- 试验地点
- 1
- 主要终点
- Number of Participants Who Discontinued Before 6 Months of Treatment
研究概览
简要总结
The primary objective is:
- to describe adherence (and the main factors influencing adherence) to PTH(1-84) treatment when prescribed in a normal clinical setting.
The secondary objectives are:
- to describe the demographics and clinical characteristics of the patients that in a normal clinical setting are started on a treatment regimen with PTH(1-84)
- to describe (using available data) the long term treatment effectiveness during the 24 months following initiation of PTH(1-84) treatment in a normal clinical setting
- to monitor safety for 24 months following initiation of PTH(1-84) treatment in a patient in a normal clinical setting.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •According to the current Summary of Product Characteristics (SmPC)
- •PTH(1-84) treatment initiated within one month preceding enrolment
- •The patient's written informed consent to direct access and data processing must be obtained.
排除标准
- •According to the current SmPC
- •The patient cannot participate in a clinical trial with PTH (all other trials allowed).
研究组 & 干预措施
Parathyroid Hormone (PTH) (1-84)
PTH(1-84) was prescribed in accordance with the terms of the marketing authorization. Participants were observed for 24 months.
干预措施: Parathyroid Hormone (PTH) (1-84) (Drug)
结局指标
主要结局
Number of Participants Who Discontinued Before 6 Months of Treatment
时间窗: 6 months
A participant was defined as "permanently discontinued" if treatment with PTH(1-84) was not ongoing at the 6-month time point and at any future time points afterwards.
次要结局
- Treatment Compliance by Visit(From enrollment to 3, 6, 12, 18, and 24 months)
- Number of Participants Who Discontinued Before 3, 12, 18, and 24 Months of Treatment(From enrollment to 3, 12, 18, and 24 months)
- Duration of Treatment(24 months)
研究者
研究点 (1)
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