Trial · NCT04354896
The Effect of Thyroid Hormone Therapy on Muscle Mass and Function in Older Adults With Subclinical Hypothyroidism
NCT04354896, Phase 4, Completed, Insel Gruppe AG, University Hospital Bern
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. The Effect of Thyroid Hormone Therapy on Muscle Mass and Function in Older Adults With Subclinical Hypothyroidism. Trials, record NCT04354896. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04354896
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The Effect of Thyroid Hormone Therapy on Muscle Mass and Function in Older Adults With Subclinical Hypothyroidism
- NCT number
- NCT04354896
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 322 participants, actual
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Conditions
- Subclinical Hypothyroidism, Sarcopenia
- Interventions
- Levothyroxin, Placebo
- First posted
- 2020-04-21
- Last updated
- 2023-05-18
- Other registries' IDs
- eudract:2011-004554-26, eudract:2012-004160-22
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Physical performance | Final visit (12 to 42 months after baseline visit) | Gait speed (3-meter and 6-meter walk test) \[m/s\] |
| Secondary | Muscle mass | Baseline, 1-year follow up and/or 2-year follow-up (yearly change) | ALM/BMI, i.e. appendicular lean mass (ALM) assessed with Dual-Energy X-Ray Absorptiometry \[kg\], divided by body mass index \[kg/m2\] |
| Secondary | Muscle strength | Baseline, 1-year follow-up | Handgrip strength, measured with a Jamar isometric Dynamometer \[kg\] |
| Secondary | Sarcopenia | Final visit (12 to 42 months after baseline visit) | Sarcopenia diagnostic criteria are applied to each participant with all three Outcomes (gait speed, handgrip strength, DXA) at the end of follow-up. E.g., a participant is diagnosed with sarcopenia when muscle mass measured with DXA is decreased (ALM/BMI for men \< 0.79, for women \< 0.51), in the presence of impaired grip strength (for men \<27 kg, for women \<16 kg). If present, sarcopenia is further classified as "severe" in presence of a gait speed\<0.8 m/s. The proportion of sarcopenic individuals between the levothyroxine and the placebo groups is then compared. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04354896
GET https://conductscience.org/api/trials/v1/NCT04354896/registered