CompletedNot Applicable

Skeletal Muscle Effects of GH in Boys

United States45 participantsStarted 2019-07-22

Plain-language summary

The purpose of the study is to measure the functional effects of recombinant GH in skeletal muscle, in addition to growth promotion, in short prepubertal boys with either growth hormone deficiency or idiopathic short stature. Patients will be similarly short. The investigators will also compare these values in the short stature cohort to those obtained in testing performed in normally growing age-matched healthy control boys not on GH. The group on GH will be studied before and after 6 and 12 months of GH treatment.

Who can participate

Age range6 Years – 11 Years

SexMALE

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Inclusion criteria

✓. 30 boys between 6-11 years of age
✓. Prepubertal
✓. Short stature (height ≤ -2SDS) due to either GH deficiency or idiopathic
✓. Stable treatment of other pituitary hormone deficiencies
✓. Naïve to GH therapy, or GH discontinued at least 6 months prior to study
✓. 15 boys between 6-11 years of age
✓. Prepubertal
✓. Normal height (10th to 90th%)

Exclusion criteria

✕. Actively growing brain tumors
✕. Chronic medical conditions that could affect study outcomes
✕. Long-term steroid use
✕. Intense regular physical training programs or organized team sports

What they're measuring

Skeletal muscle strength (Newtons)

Timeframe: 12 months

Trial details

NCT IDNCT04020913

SponsorNemours Children's Clinic

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-09-30

View on ClinicalTrials.gov More Growth Hormone Deficiency trials