EUCTR2004-002255-14-CZ进行中（未招募）1 期
Randomized, double-blind, double-dummy, parallel group, multicenter study to compare the efficacy and safety of once-monthly oral administration of 150 mg ibandronate with once-weekly oral administration of 70 mg alendronate in postmenopausal osteoporosis - Non-inferiority trial
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,786
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
- Female
入选标准
- •- Women, at least five years after menopause
- •- Age 55 to 84 years
- •- -5.0 SD =Mean lumbar spine BMD (L2-L4) T-score < -2.5 SD
- •- Written informed consent
- •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
- •- Inability to stand or sit upright for 60 mn
- •- Hypersensitivity to bisphosphonates and to any of their components
- •- Contra-indications for calcium or vitamin D therapy
- •- Vitamin D deficiency (serum 25-hydroxy vitamin D < 16ng/ml, equivalent to 40 nmol/l)
- •- Renal impairment (creatinine clearance< 35 mL/min, using Cockroft and gault equation)
- •- History of major upper GI disease
- •- Malignant disease diagnosed within the previous 10 years(except successfully resected basal cell cancer), breast cancer diagnosed within the previous 20 years
- •- Active disease/disorder known to influence bone metabolism
- •- Previous treatment with other drugs affecting bone metabolism
研究者
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