Novel Biomarkers and Skeletal Outcomes Associated With Subclinical Thyroid Dysfunction

PHASE4CompletedINTERVENTIONAL
Enrollment

145

Participants

Timeline

Start Date

January 31, 2014

Primary Completion Date

December 31, 2016

Study Completion Date

December 31, 2016

Conditions
Thyroid DysfunctionBone Mineral DensityOsteoporosisFractures, Bone
Interventions
DRUG

Levothyroxine

The intervention will start with Levothyroxine 50 mcg daily (reduced to 25 mcg in subjects \<50 kg of body weight or if known coronary heart disease - previous myocardial infarction or symptoms of angina pectoris) vs. matching placebo; at 3 months, if the serum TSH level is \<0.4 mU/L, dose will be reduced by 25 mcg; TSH \>=0.4 and \<4.6 mU/L, no change to dose; TSH \>=4.6 mU/L, additional 25 mcg. The process will be repeated at 12 months, then annually; mock titration will be performed in the placebo group. The maximum possible dose of Levothyroxine which will be prescribed is 150 mcg (after 4 increments of 25 mcg at 3 months, 1, 2, 3 years; from the starting dose of 50 mcg).

DRUG

Placebo

"Control patients will obtain a placebo pill of the same characteristics as the intervention drug, and mock titration will be carried out identically to the intervention drug.~Pharmaceutical composition of placebo (100 mg): Lactose monohydrate 66 mg, Maize starch 25 mg, Gelatin 5 mg, Croscarmellose sodium 3.5 mg, Magnesium stearate (vegetable source) 0.5 mg."

Trial Locations (2)

1011

Department of General Internal Medicine, Lausanne

3010

Clinic for General Internal Medicine, Bern University Hospital Bern, Bern

All Listed Sponsors
collaborator

University of Lausanne Hospitals

OTHER

lead

Insel Gruppe AG, University Hospital Bern

OTHER

NCT02491008 - Novel Biomarkers and Skeletal Outcomes Associated With Subclinical Thyroid Dysfunction | Biotech Hunter | Biotech Hunter