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临床试验/DRKS00000721
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

发起方
Evangelisches Krankenhaus Lutherhaus gGmbH

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