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

Completed

• Conditions: Thyrotoxic symptoms, nodular goiter, hyperthyroidism; Thyrotoxicosis [hyperthyroidism]; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN04337637
• Lead Sponsor: niversity Medical Centre St Radboud (Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09-12
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 192

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified