EUCTR2004-000248-25-ES进行中(未招募)不适用
A multinational, multicenter, randomized, double-blind,double-dummy, stratified, active controlled parallel groupstudy comparing the efficacy and safety of intravenouszoledronic acid, 5 mg once yearly, and oral risedronate, 5mg daily, in the prevention and treatment of corticosteroidinduced osteoporosis - 2306
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
- 900
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
- •(for full list see protocol):
- •Male and female patients 18 to 85 years age old
- •Patients treated with at least 7.5 mg of oral prednisone per day (or equivalent systemic corticosteroid) and expected to continue corticosteroids therapy for at least a 12 month period:
- •Treated for less or equal to 3 months prior to study entry (prevention sub-population)
- •Treated for more than 3 months prior to study entry (treatment sub-population).
- •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
- •(for full list see protocol):
- •Any prior use of bisphosphonate preparations except according to the washout schedule at
- •time of randomization:
- •2 years (if use >48 weeks)
- •1 year (if used >8 weeks but <48 weeks)
- •6 months (if used >2 weeks but <8 weeks)
- •2 months (if used <2 weeks)
- •Any prior use of i.v. bisphosphonate within 2 years prior to randomization
研究者
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A multinational, multicenter, randomized, double-blind,double-dummy, stratified, active controlled parallel groupstudy comparing the efficacy and safety of intravenouszoledronic acid, 5 mg once yearly, and oral risedronate, 5mg daily, in the prevention and treatment of corticosteroidinduced osteoporosis - 2306corticosteroid induced osteoporosisEUCTR2004-000248-25-CZovartis Pharma AG900
