DRKS00000721进行中(未招募)3 期
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 个研究点目标入组 424 人开始时间: 2012年2月22日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 424
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 60 Years 至 one(—)
- 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
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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