NCT00515593已完成不适用
Non-interventional Open Single Arm, Multicentre Study to Observe the Use of Preotact in Patients With Severe Postmenopausal Osteoporosis
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Nycomed
- 入组人数
- 110
- 试验地点
- 1
研究概览
简要总结
The objectives of the study are
- to describe the quality of life at the beginning of the Preotact® treatment and at the end of the observational period (Qualeffo-41 questionnaire)
- pain assessment at the beginning of the Preotact® treatment and at the end of the observational period (VAS score)
- to describe bone mineral density at the beginning of the Preotact® treatment and at the end of the observational period (T-Score)
- to describe incidence of bone fractures caused by osteoporosis as well as of other pathological findings of the skeleton after the beginning of the Preotact® treatment
- to describe serum level of calcium and the bone resorption marker desoxypyridinoline (DPD) and N- respectively C-terminal crosslink-telopeptide (CTX and NTX) at the beginning of the Preotact® treatment and at the end of the observational period (only in subgroup of patients, where the physician sees a need to measure these parameters)
- to document all adverse drug reactions after the beginning of the Preotact® treatment
- the analysis of subgroups with different risk for bone fractures caused by osteoporosis at the beginning of the Preotact® treatment
- to assess the manageability and functioning of the Pen system for injection of Preotact® (self administered questionnaire)
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Inclusion requires that Preotact® is prescribed in accordance with the SPC and that the stated contraindications are strictly considered.
- •Caution should be taken by the treating Physician concerning any precautions, warnings and potential drug interactions stated in the SPC.
- •No further inclusion or exclusion parameters are defined. The decision for the individual application of Preotact® will be strictly made by the physicians.
排除标准
- 未提供
研究者
研究点 (1)
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