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临床试验/NCT00515593
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

Nycomed1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2006年9月最近更新:
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

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

发起方
Nycomed
申办方类型
Industry

研究点 (1)

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