EUCTR2009-013935-39-BE进行中（未招募）不适用
The efficacy and safety of a daily oral administration of S06911 (strontium ranelate 2g/vitamin D3 1000 IU fixed combination) on vitamin D insufficiency in the treatment of osteoporotic postmenopausal women and men. A prospective, international phase III study with a 6-month double-blind period to assess the efficacy and safety of a daily oral administration of S06911 versus S12911 (strontium ranelate 2g) and a 6-month open-labelled extension for a subgroup of patients to assess safety of a daily oral administration of S06911.
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
- 500
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 men and postmenopausal osteoporotic women
- •- Superior or equal to 50 year
- •- Caucasian
- •- Body mass index inferior to 30 kg/m2
- •- 25-OH vitamin D concentration >22.5 nmol/L
- •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 305
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 213
排除标准
- •- Progressive major illness, uncontrolled active disease, skeletal disease
- •- History or increased risk of deep venous thrombosis or pulmonary embolism
- •- History of intolerance, allergy or severe hypersensitivity with study drugs
- •- History of alcohol abuse or drug dependance
研究者
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