EUCTR2009-017039-16-CZ进行中（未招募）不适用
Effect of strontium ranelate (2g per day) in the management of long bone fractures with delayed-union or non union: an international open label 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
- 40
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 aged 18 years and postmenopausal women with a fracture of the limb or clavicle with delayed union, defined as an absence of radiological full union after 6 months according to investigator’s opinion OR
- •with Non-union defined as non-union for at least 6 months and no sign of radiological healing or bone reaction since at least 3 months,
- •Ambulatory prior to the qualifying 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 27
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 13
排除标准
- •Not pathological fracture,
- •Bone-related disease other than osteoporosis,
- •Septic or synovial or congenital pseudarthrosis,
- •Fracture with a fracture gap, after reduction or treatment, greater than more the half the width of the affected bone,
- •Concomitant treatments interfering with bone metabolism,
- •History of venous thrombo-embolism,
- •History of intolerance, allergy or hypersensitivity to strontium ranelate,
- •Contraindication to Calperos D3.
研究者
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