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
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
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