Novel Biomarkers and Skeletal Outcomes Associated With Subclinical Thyroid Dysfunction

• Status: Completed
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Thyroid hormone is a key regulatory hormone for a range of physiological systems, including the skeleton. Previous studies have suggested that subclinical thyroid dysfunction (SCTD) may be associated with deleterious skeletal effects. However, controversy persists on the clinical relevance of SCTD as well as on optimal thresholds for treatment. Available data have substantial limitations: 1) limited prospective data are available to assess the associations between SCTD and non-cardiovascular outcomes, such as fractures 2) lack of data from large RCTs to investigate the pathophysiological mechanisms of associations between thyroid hormone and bone loss. The aim of the study is to examine the relationship between subclinical hypothyroidism and thyroid hormone replacement in regard to skeletal fragility, bone mineral density (BMD), bone loss and metabolism, and the risk of fractures in elderly participants. The listed parameters will be assessed by dual energy X ray absorptiometry (DXA) and novel bone imaging techniques at baseline, at 1 year of follow-up. The study will be nested in the TRUST trial (clinicaltrials.gov ID: NCT01660126), and will make use of its study infrastructure to determine bone biomarkers from biospecimens at baseline, and at 1 year of follow-up from 145 Swiss participants with persistent subclinical hypothyroidism randomized to either thyroxine or placebo in Bern and Lausanne.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital Inselspital, Berne
• Collaborator: University of Lausanne Hospitals
• Treatments: Carboxymethylcellulose Sodium

Criteria

Inclusion Criteria:

• Community-dwelling patients aged >= 65 years with subclinical hypothyroidism

• Written informed consent

Exclusion Criteria

• Subjects currently under levothyroxine or antithyroid drugs (amiodarone, lithium)

• Recent thyroid surgery or radio-iodine (within 12 months)

• Grade IV NYHA heart failure

• Prior clinical diagnosis of dementia

• Recent hospitalization for major illness or elective surgery (within 4 weeks)

• Terminal illness

• Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption

• Subjects who are participating in ongoing RCTs of therapeutic interventions (including CTIMPs)

• Plan to move out of the region in which the trial is being conducted within the next 2 years (proposed minimum follow-up period)