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临床试验/ISRCTN04337637
ISRCTN04337637已完成不适用

Subclinical Hyperthyroidism 'To Treat or Not to Treat?' - A Dutch Multicentre Trial

niversity Medical Centre St Radboud (Netherlands)0 个研究点目标入组 192 人开始时间: 2005年9月12日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
192

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

性别
All

入选标准

  • 1. Subclinical hyperthyroidism [TSH <= 0.1 mU/L, fT4 and T3 within the normal range of the own laboratory (determined 2 times in own laboratory with an interval of at
  • least 2 months)
  • 2. Endogenous cause of subclinical hyperthyroidism limited to autonomous adenoma or multinodular goiter (diagnosis made by the attending physician, based on palpation and the result of a thyroid scintigram)
  • 3. Informed consent

排除标准

  • 1. Medication with anti-thyroid drugs in the last 3 months (also not allowed during follow-up), thyroid hormone in the last 3 months (allowed during follow-up, but TSH levels should be kept between 0.1 mU/L and the upper limit of normal in the own laboratory) and oral glucocorticoids in the last 3 months (allowed during follow-up when absolutely necessary, but patients in whom glucocorticoids are
  • started cannot be evaluated with respect to changes in BMD).
  • 2. Radioiodine therapy in the past
  • 3. Iodine-induced subclinical hyperthyroidism
  • 4. Pituitary or hypothalamic insufficiency
  • 5. Pregnancy
  • 6. Age <= 50 years and > 80 years
  • 7. Severe non-thyroidal illness
  • 8. Drug abuse
  • 9. Unstable angina pectoris, (history of) atrial fibrillation, (history of) congestive heart failure.
  • 10. (History of) osteoporotic fracture(s)
  • 11. Patients younger than 70 years of age with a bone mineral density T-score <2.5
  • SD, or older than 70 years of age with a bone mineral density Z-score <-1.0 SD
  • 12. These patients can be randomised but in case it is decided to treat them with antiosteoporotic drugs they cannot be evaluated with respect to changes in BMD.
  • 13. Use of betablockers in the last three months. These patients can be randomised but cannot be evaluated with respect to
  • general and cardiac symptoms. The same applies to patients in whom betablockers are started during follow up.
  • 14. Other symptoms or signs of hyperthyroidism or obstruction of vital structures which in the opinion of the attending physician urge to active treatment.

研究者

发起方
niversity Medical Centre St Radboud (Netherlands)

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