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CompletedNCT00150124Updated Dec 4, 2013

Block-replacement Therapy During Radioiodine Therapy

A Phase 4 interventional study of MTZ+LT4 and Methimazole in Toxic Nodular Goitre and Graves' Disease, sponsored by Steen Bonnema. Completed at 1 site in Denmark. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2013-12-04.

Sponsored by Steen Bonnema · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

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Conditions studied

  • Toxic Nodular Goitre
  • Graves' Disease

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Keywords

  • Radioiodine therapy
  • Graves' disease
  • toxic nodular goiter
  • antithyroid drugs
  • levothyroxine
  • radioprotection
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In context

Graves Disease

162 studies on the registry are indexed under Graves Disease; 53 are open to participants now.

This study's enrollment of 100 is above the median of 60 across 104 interventional studies indexed under Graves Disease.

Browse Graves Disease studies →

Lead sponsor

Steen Bonnema is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Hyperthyroid patients going to be treated with radioiodine either due to recurrent Graves' disease or toxic nodular goiter.

Exclusion criteria

Exclusion Criteria:

  • Age \< 18 yrs.
  • Allergy to anti-thyroid drugs
  • Substernal or large (> 100ml) goiter
  • Severe endocrine ophthalmopathy
  • Pregnancy or lactation
  • Suspicion of thyroid
  • Unsafe contra-conception
  • Physical or mental condition that hinders corporation
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (actual)

Study arms

  • Experimental
    block-replacement therapy

    BRT regimen until 3 months after 131I therapy

    Drug: MTZ+LT4

  • Active comparator
    methimazole

    methimazole stopped 8 days before 131I therapy

    Drug: Methimazole

Interventions

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What researchers measure

Primary outcomes

  1. Thyroid function after one year of follow-up

    Time frame: one year

Secondary outcomes

  1. Thyroid radioiodine 131I uptake

    Time frame: one month

  2. Thyroid volume after one year of follow-up

    Time frame: one year

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Study locations

1 site
  • Department of Endocrinology, Odense University Hospital
    Odense, Funen 5000, Denmark
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References and documents

Publications

  • Bonnema SJ, Grupe P, Boel-Jorgensen H, Brix TH, Hegedus L. A randomized trial evaluating a block-replacement regimen during radioiodine therapy. Eur J Clin Invest. 2011 Jul;41(7):693-702. doi: 10.1111/j.1365-2362.2010.02452.x. Epub 2010 Dec 22. PubMed 21175612 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 4, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00150124
Lead sponsor
Steen Bonnema
Responsible party
Steen Bonnema (Consultant, phd, DMSc, Odense University Hospital) — Sponsor-investigator
First posted
Sep 8, 2005
Start date
Jan 2003
Primary completion
Dec 2008
Completion
Mar 2009
Last update
Dec 4, 2013

Study contacts

Steen J. Bonnema, MD, PhD
principal investigator · Odense University Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.

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