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临床试验/EUCTR2010-020215-36-BE
EUCTR2010-020215-36-BE进行中(未招募)1 期

A prospective, controlled, double blind, international study to assess the effects of strontium ranelate vs. placebo on the reduction of periprosthetic bone loss in patients with total hip arthroplastyThe Periprosthetic bone loss” study - The Periprosthetic bone loss” study

Institut de Recherches Internationales Servier0 个研究点目标入组 126 人开始时间: 2012年4月25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)
入组人数
126

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
All

入选标准

  • Caucasian men or postmenopausal women,
  • Age = 50 years,
  • Patients with conventional primary total hip arthroplasty, cementless femoral stem and primary coxarthrosis as indication of total hip arthroplasty.
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 38
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 88

排除标准

  • ­Short femoral stem,
  • ­Any perioperative complication,
  • ­Patients with inflammatory arthropathy,
  • Impossibility to perform DXA,
  • Increased risk or history of VTE,
  • Known hypersensitivity or contraindication to the study drug or Calperos D3®.

研究者

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