Block-replacement Therapy During Radioiodine Therapy
Information source: Odense University Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Toxic Nodular Goitre; Graves' Disease
Intervention: MTZ+LT4 (Drug); Methimazole (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Steen Bonnema Official(s) and/or principal investigator(s): Steen J. Bonnema, MD, PhD, Principal Investigator, Affiliation: Odense University Hospital
Summary
Background: The use of radioactive iodine (131I) therapy as the definite cure of
hyperthyroidism is widespread. According to a survey on the management of Graves' disease,
thirty per cent of physicians prefer to render their patients euthyroid by antithyroid drugs
(ATD) prior to 131I therapy. This strategy is presumably chosen to avoid 131I induced
'thyroid storm', which, however, is rarely encountered. Several studies have consistently
shown that patients who are treated with ATD prior to 131I therapy have an increased risk of
treatment failure. Mostly, patients with Graves' disease have been studied, while other
studies were addressed also toxic nodular goiter. Thus, it is generally accepted that ATD
have 'radioprotective' properties, although this view is almost exclusively based on
retrospective data and is still under debate. Indeed, this dogma was recently challenged by
two randomized trials in Graves' disease, none of which showed such an adverse effect of
methimazole pretreatment. It cannot be excluded that the earlier results may have been under
influence of selection bias, a source of error almost unavoidable in retrospective studies.
Whether ATD is radioprotective also when used in the post 131I period has also been debated.
In the early period 131I therapy following a transient rise in the thyroid hormones is seen
which may give rise to discomfort in some patients. The continuous use of ATD during 131I
therapy, possibly in combination with levothyroxine (BRT: block-replacement therapy), leads
to more stable levels of the thyroid hormones. By resuming ATD following 131I therapy,
euthyroidism can usually be maintained until the destructive effect of 131I ensues.
Nevertheless, many physicians prefer not to resume ATD, probably due to reports supporting
that such a strategy reduces the cure rate. Parallel to the issue of ATD pretreatment, the
evidence is based on retrospective studies and the ideal set-up should be reconsidered. To
underscore the importance of performing randomized trials we showed recently that
resumption of methimazole seven days after 131I therapy had no influence on the final
outcome.
Aim: To clarify by a randomized trial whether BRT during radioiodine therapy of hyperthyroid
patients influences the final outcome of this therapy, in a comparison with a regime in
which methimazole as mono-therapy is discontinued 8 days before radioiodine.
Patients and Methods: Consecutive patients suffering from recurrent Graves' disease (n=50)
or a toxic nodular goiter (n=50) are included. All patients are rendered euthyroid by
methimazole (MMI) and randomized either to stop MMI eight days before 131I or to be set on
BRT. This latter medication continues until three months after 131I. Calculation of the 131I
activity (max. 600 MBq) includes an assessment of the 131I half-life and the thyroid volume.
Patients are followed for one year with close monitoring of the thyroid function.
Clinical Details
Official title: The Influence of Continuous Block-replacement Therapy on the Effect of Radioiodine in Patients With Hyperthyroidism
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Thyroid function after one year of follow-up
Secondary outcome: Thyroid radioiodine 131I uptakeThyroid volume after one year of follow-up
Eligibility
Minimum age: 18 Years.
Maximum age: 85 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Hyperthyroid patients going to be treated with radioiodine either due to recurrent
Graves' disease or toxic nodular goiter.
Exclusion Criteria:
- Age < 18 yrs.
- Allergy to anti-thyroid drugs
- Substernal or large (> 100ml) goiter
- Severe endocrine ophthalmopathy
- Pregnancy or lactation
- Suspicion of thyroid malignancy
- Unsafe contra-conception
- Physical or mental condition that hinders corporation
Locations and Contacts
Department of Endocrinology, Odense University Hospital, Odense, Funen 5000, Denmark
Additional Information
Starting date: January 2003
Last updated: December 3, 2013
|