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临床试验/EUCTR2016-000431-40-FR
EUCTR2016-000431-40-FR进行中(未招募)1 期

Randomized controlled study evaluating the effect of a biotherapy treatment (anti-RANKL ligand antibody: Denosumab) on bone and vascular metabolism in osteoporotic chronic kidney disease - HDENO

Health Ministry0 个研究点开始时间: 2016年6月17日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
Female

入选标准

  • Patient female of 65 years or older
  • Chronic kidney disease stage 5 patient, hemodialyzed with extracorporeal treatment for at least 3 months
  • History of vertebral fracture
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) no
  • F.1.2.1 Number of subjects for this age range 0
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 30

排除标准

  • Cinacalcet treatment
  • Substitutive hormonal treatment
  • Calcium phosphate balance (PTH, 25(OH) vitamin D3, Calcium, phosphate) outside the KDIGO guidelines
  • Hypersensibility to active substance or one of excipients of Prolia®

研究者

发起方
Health Ministry

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