Status:
COMPLETED
Skeletal Muscle Effects of GH in Boys
Lead Sponsor:
Nemours Children's Clinic
Collaborating Sponsors:
Novo Nordisk A/S
Conditions:
Growth Hormone Deficiency
Idiopathic Short Stature
Eligibility:
MALE
6-11 years
Brief 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 ...
Detailed Description
Prepubertal boys with significant short stature (height SDS ≤-2.0) diagnosed with either GH deficiency or idiopathic short stature (ISS) who are identified as candidates for GH treatment will recruite...
Eligibility Criteria
Inclusion
- 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%)
Exclusion
- 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
Key Trial Info
Start Date :
July 22 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 30 2025
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT04020913
Start Date
July 22 2019
End Date
October 30 2025
Last Update
November 4 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Nemours Children's Clinic
Jacksonville, Florida, United States, 32207