Ignite Creation Date:
2024-05-05 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00150124
Status:
COMPLETED
Last Update Posted:
2013-12-04
First Post:
2005-09-06
Brief Title:
Block-replacement Therapy During Radioiodine Therapy
Sponsor:
Steen Bonnema
Organization:
Odense University Hospital
Study Overview
Official Title:
The Influence of Continuous Block-replacement Therapy on the Effect of Radioiodine in Patients With Hyperthyroidism
Status:
COMPLETED
Status Verified Date:
2013-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
AimTo 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 n50 or a toxic nodular goiter n50 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
AimTo 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 n50 or a toxic nodular goiter n50 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None