EUCTR2009-017039-16-IT进行中（未招募）不适用
Effect of strontium ranelate (2g per day) in the management of lower limb fractures with delayed-union or non union: an international open label study in patients with osteoporosis - ND
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
- •- Osteoporotic patients, - With a fracture of the lower limbs 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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
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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