跳至主要内容
临床试验/EUCTR2009-014271-41-CZ
EUCTR2009-014271-41-CZ进行中(未招募)不适用

A multicenter, prospective, randomized, double-blind, placebo-controlled, international study to assess the effects of 2g per day of strontium ranelate versus placebo on the time to fracture healing in osteoporotic men and women. - The fracture healing study

Institut de Recherches Internationales Servier0 个研究点目标入组 200 人开始时间: 2010年1月5日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
200

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

  • - Men or postmenopausal women, aged = 50 years
  • - Osteoporotic patient with a fracture of the distal radius (Colles’ fracture)
  • 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 110
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 90

排除标准

  • - Multiple trauma with serious lesions and/or fractures in other anatomical regions
  • - ­Known skeletal disease
  • - Displaced fracture
  • - Fracture requiring surgical intervention
  • - Associated fracture of the ulnar shaft
  • - Fracture of the dorsal/volar margin (Barton or reverse Barton fracture).
  • - Volar angulation (Smith fracture or reverse Colles’ fracture).
  • - Vertical fracture and/or fracture of the radial styloid
  • ­- History or increased risk of venous thrombo-embolism
  • - Known liver insufficiency or renal insufficiency

研究者

相似试验

进行中(未招募)
1 期
A multicenter, prospective, randomized, double-blind, placebo-controlled, international study to assess the effects of 2g per day of strontium ranelate versus placebo on the time to fracture healing in osteoporotic men and women. - The fracture healing study
EUCTR2009-014271-41-GBInstitut de Recherches Internationales Servier200
进行中(未招募)
1 期
Efficacy of strontium ranelate versus placebo on the time to fracture healing in osteoporotic men and osteoporotic post-menopausal womeOsteoporotic men and post menopausal osteoporotic women with a fracture of the distal radiusMedDRA version: 14.0Level: LLTClassification code 10031288Term: Osteoporosis with fractureSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
EUCTR2009-014271-41-BEInstitut de Recherches Internationales Servier200
进行中(未招募)
不适用
A multicenter, prospective, randomized, double-blind, placebo-controlled, international study to assess the effects of 2g per day of strontium ranelate versus placebo on the time to fracture healing in osteoporotic men and women. - The fracture healing studyOsteoporotic men and post menopausal osteoporotic women with a fracture of the distal radiusMedDRA version: 12.1Level: LLTClassification code 10031288Term: Osteoporosis with fracture
EUCTR2009-014271-41-HUInstitut de Recherches Internationales Servier200
进行中(未招募)
不适用
Efficacity of strontium ranelate versus placebo on the time to fracture healing in osteoporotic men and osteoporotic post-menopausal wome
EUCTR2009-014271-41-DEInstitut de Recherches Internationales Servier200
进行中(未招募)
不适用
A multicenter, prospective, randomized, double-blind, placebo-controlled, international study to assess the effects of 2g per day of strontium ranelate versus placebo on the time to fracture healing in osteoporotic men and women. - The fracture healing studyOsteoporotic men and post menopausal osteoporotic women with a fracure of the distal radiusMedDRA version: 9.1Level: LLTClassification code 10031288
EUCTR2009-014271-41-ITINSTITUT DE RECHERCHES INTERNATIONALES SERVIER200