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临床试验/EUCTR2013-001222-26-DK
EUCTR2013-001222-26-DK进行中(未招募)1 期

Markers of bonestatus in Diabetes Mellitus patients (type 1 and type 2) andthe effect of antiresorptive treatment on glycemic markers.

Aalborg University Hospital0 个研究点目标入组 64 人开始时间: 2013年7月9日最近更新:
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
64

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

  • Type 1 diabetes / type 2 diabetes
  • Age = 50 år.
  • Same medical diabetes treatment the last six months (dose changes
  • is allowed)and HbA1c changes on ± 1 in the same period.
  • HbA1c level= 6,7% in the last six months.
  • Body mass index (BMI) between 19 og 35.
  • DXA T-score: -3,5 til -0,5.
  • 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 32
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 32

排除标准

  • HbA1C > 10%
  • Pregnancy.
  • Metal implanted at ancle and wrist at all four ekstremities.
  • Treatment by: Antiresorptives (inkl. HRT) or bone anabolic drugs,
  • glucocorticoids, lithium og anticonvulsives.
  • Patients with bone disease different from Osteoporosis.
  • Vertebral fraktur synlig ved VFA.
  • Patients with kidney disease defined by eGFR < 50.
  • Other significant medical disease in unstable phase (like cancer or
  • hyperthyroidism)
  • Heart failure in NYHA class IV.
  • Previous allergic reactions to the trial drug.
  • Previous allergic reactions to tetracyklin.
  • Abnormities in esophagus and other factors, which may delay the transit tim in the esophagus.
  • Unable to stand or sit for 30 consecutive minutes.
  • The investigator considers the patient unfit to participate.
  • Patient with no understanding of the extent of the trial.

研究者

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