Skeletal Muscle Effects of GH in Boys

Completed

Conditions studied: Growth Hormone Deficiency, Idiopathic Short Stature

In brief

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.

Key facts

Study ID

NCT04020913

Run by

Nemours Children's Clinic

People needed

45

Starts

2019-07-22

Expected to finish

2025-10-30

Last updated by the study team

2025-11-04

Who can join

Age: 6 and older, up to 11. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• Short Stature Group
• 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
• Normal Stature Group
• 15 boys between 6-11 years of age
• Prepubertal
• Normal height (10th to 90th%)

You may not qualify if…

• 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

Where it is running

• Nemours Children's Clinic — Jacksonville, Florida, United States

Full record on ClinicalTrials.gov

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