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
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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