Novel Biomarkers and Skeletal Outcomes Associated With Subclinical Thyroid Dysfunction
Status:
Completed
Trial end date:
2016-12-01
Target enrollment:
Participant gender:
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.