Status:
UNKNOWN
Does Radioiodine Treatment Prevent Atrial Fibrillation and Bone Loss in Endogenous Subclinical Hyperthyroidism?
Lead Sponsor:
Radboud University Medical Center
Conditions:
Hyperthyroidism
Eligibility:
All Genders
40+ years
Phase:
NA
Brief Summary
Subclinical hyperthyroidism is defined as the presence of serum free thyroxine (T4) and triiodothyronine (T3) levels within the reference range and a reduced serum thyrotrophin (TSH) level. Evidence i...
Eligibility Criteria
Inclusion
- Subclinical hyperthyroidism \[TSH ≤ 0.1 mU/L, fT4 and T3 within the normal range of the own laboratory (determined 2 times in own laboratory) with an interval of at least 2 months\].
- 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).
- Informed consent.
Exclusion
- 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 bone mineral density \[BMD\]).
- Radioiodine therapy in the past.
- Iodine-induced subclinical hyperthyroidism.
- Pituitary or hypothalamic insufficiency.
- Pregnancy.
- Age \<= 40 years.
- Severe non-thyroidal illness.
- Drug abuse.
- Unstable angina pectoris, (history of) atrial fibrillation, (history of) congestive heart failure.
- (History of) osteoporotic fracture(s).
- Patients younger than 70 years of age with a bone mineral density T-score \< - 2.5 standard deviations (SD), or older than 70 years of age with a bone mineral density Z-score \< 1.0 SD. (These patients can be randomized but in case it is decided to treat them with anti-osteoporotic drugs they cannot be evaluated with respect to changes in BMD.)
- 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.)
- Other symptoms or signs of hyperthyroidism or obstruction of vital structures which, in the opinion of the attending physician, require active treatment.
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00151723
Start Date
April 1 2004
Last Update
July 18 2007
Active Locations (5)
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1
Academical Medical Centre Amsterdam
Amsterdam, Netherlands
2
Martini Ziekenhuis Groningen
Groningen, Netherlands
3
University Hospital Groningen
Groningen, Netherlands
4
Radboud University Medical Centre Nijmegen
Nijmegen, Netherlands, 6500HB