EUCTR2011-000290-31-DE进行中（未招募）不适用
Comparison of the effect of an ongoing treatment with alendronate or a drug holidayon the fracture risk in osteoporotic patients with a bisphosphonate long term therapy - BILANZ
Evangelisches Krankenhaus Lutherhaus gGmbH0 个研究点开始时间: 2011年9月9日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •Postmenopausal women or men > 60 years,
- •DXA T-Score at lumbar spine, total hip or femur neck <-2,0 OR at least one low traumatic vertebral fracture grade 2/3 or multiple low traumatic vertebral fractures regardless of bone density Pretreatment with bisphosphonates for at least four years
- •Risk for hip and vertebral fractures min. 30% according to DVO-guideline for osteoporosis 2009
- •Signed 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 1000
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 6000
排除标准
- •Other pharmacological treatment of osteoporosis during the last 48 months
- •Other bone diseases
- •Malabsorption syndromes
- •Renal insufficiency with a calculated creatinine clearance < 35 ml/min Diseases of the esophagus, delayed esophageal clearance
- •Unrealisability of the intake instructions
- •Hypocalcemia
研究者
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