Clinical Trial: Post-Radioiodine Graves' Management: The PRAGMA-Study

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: POST-RADIOIODINE GRAVES' MANAGEMENT

Brief Summary: Thyroid dysfunction following radioiodine for Graves' disease is common, potentially detrimental and avoidable. A variety of clinical strategies are employed in the post-radioiodine era util the patient is on a stable thyroid hormone replacement regimen, which include the use of anti-thyroid drugs, antithyroid drugs with thyroxine, early thyroxine replacement and watchful monitoring until the onset of hypothyroidism. Which of these is most effective in avoiding dysthyroidism, is unknown. This study aims to address this lack of evidence. It will focus on Graves' disease as this is the commonest cause of thyrotoxicosis and the commonest indication for RI therapy. It will provide an insight into potential strategies for improving important clinical outcomes.

Detailed Summary:
Sponsor: Newcastle-upon-Tyne Hospitals NHS Trust

Current Primary Outcome: Incidence of dysthyroidism post-RI between different post-RI management strategies employed by clinicians in the UK [ Time Frame: 12 months post radio-iodine ]

To compare the incidence of dysthyroidism post-RI between different post-RI management strategies employed by clinicians in the UK:

  • anti-thyroid drugs before and /or after RI
  • anti-thyroid drugs with levothyroxine before and / or after RI
  • watchful monitoring post-RI and introduction of levothyroxine when needed.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Graves orbitopathy [ Time Frame: 12 months post-radiodiodine ]
  • weight gain [ Time Frame: 12 months ]
  • progression of Graves' orbitopathy [ Time Frame: 12 months ]
  • patient satisfaction [ Time Frame: 12 months ]


Original Secondary Outcome: Same as current

Information By: Newcastle-upon-Tyne Hospitals NHS Trust

Dates:
Date Received: February 15, 2013
Date Started: March 2013
Date Completion:
Last Updated: March 29, 2017
Last Verified: March 2017