Osteoporosis Clinical Trial
— TRUST BONEOfficial title:
Novel Biomarkers and Skeletal Outcomes Associated With Subclinical Thyroid Dysfunction: a Prospective Evaluation and Impact of Treatment
Verified date | January 2017 |
Source | University Hospital Inselspital, Berne |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 145 |
Est. completion date | December 2016 |
Est. primary completion date | December 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 65 Years and older |
Eligibility |
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) |
Country | Name | City | State |
---|---|---|---|
Switzerland | Clinic for General Internal Medicine, Bern University Hospital Bern | Bern | |
Switzerland | Department of General Internal Medicine | Lausanne | Vaud |
Lead Sponsor | Collaborator |
---|---|
University Hospital Inselspital, Berne | University of Lausanne Hospitals |
Switzerland,
Rodondi N, den Elzen WP, Bauer DC, Cappola AR, Razvi S, Walsh JP, Asvold BO, Iervasi G, Imaizumi M, Collet TH, Bremner A, Maisonneuve P, Sgarbi JA, Khaw KT, Vanderpump MP, Newman AB, Cornuz J, Franklyn JA, Westendorp RG, Vittinghoff E, Gussekloo J; Thyroid Studies Collaboration.. Subclinical hypothyroidism and the risk of coronary heart disease and mortality. JAMA. 2010 Sep 22;304(12):1365-74. doi: 10.1001/jama.2010.1361. — View Citation
Rodondi N, Newman AB, Vittinghoff E, de Rekeneire N, Satterfield S, Harris TB, Bauer DC. Subclinical hypothyroidism and the risk of heart failure, other cardiovascular events, and death. Arch Intern Med. 2005 Nov 28;165(21):2460-6. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in bone mineral density (BMD) | baseline and one year follow up | ||
Secondary | Change in bone biomarkers | baseline and one year follow up | ||
Secondary | Bone mineral density (BMD) | 1 year follow up |
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