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临床试验/EUCTR2007-004368-34-IE
EUCTR2007-004368-34-IE进行中(未招募)不适用

The effects of statin therapy on the osteoprotegerin-RANKL system, correlation with vascular disease and bone metabolism in patients with Type 2 diabetes.

Department of Academic Endocrinology, Beaumont Hospital0 个研究点目标入组 40 人开始时间: 2008年6月4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
入组人数
40

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

  • Age > 40 years
  • Type 2 diabetes
  • HbA1c <7.5%
  • No change in diabetic treatment in last 3 months
  • Stain naïve or currently on no more than 10mg atorvastatin, 40mg pravastatin, or 20mg simvastatin.
  • 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

  • Age < 40 years
  • Intolerance to statin therapy
  • Significant hepatic disease precluding statin therapy
  • Current use of > 10mg atorvastatin, 40mg pravastatin, or 20mg simvastatin
  • Type 1 diabetes mellitus
  • Women of child bearing potential
  • Pregnant women
  • Renal dysfunction, defined as a creatinine greater than 150µmol/l
  • History of or current malignancy
  • Treatment with agents known to interfere with OPG/RANKL system such as bisphosphonates, vitamin D, strontium
  • Recent (3 months) change in diabetes treatment
  • Recent vertebral or non-vertebral fracture in the last 6 months
  • Recent (within last 6 months) cardiovascular or cerebrovascular event
  • Recent (within last 6 months) coronary angioplasty
  • Children/Minors (<18 years of age)
  • Unable to read or give informed consent

研究者

发起方
Department of Academic Endocrinology, Beaumont Hospital

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The effects of statin therapy on the... | 临床试验