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Clinical trial

Recombinant Human Growth Hormone (GH): Effects on Metabolic Profile, Body Composition and Skeletal Muscle Strength and Function in Pre-pubertal Short Boys With and Without GH Deficiency

ID
Name
#19-09
Description
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.
Trial arms
Trial start
2019-07-22
Estimated PCD
2024-05-31
Trial end
2025-07-21
Status
Active (not recruiting)
Treatment
Somatropin injection
Boys with short stature will be studied for measures of: 1. skeletal muscle strength, power, and endurance 2. muscle agility 3. lean body mass accrual 4. bone mineral density and resting energy expenditure before and after 6 months and 12 months of GH administration
Arms:
Short Stature Boys
Other names:
Recombinant Growth Hormone, Norditropin
Size
45
Primary endpoint
Skeletal muscle strength (Newtons)
12 months
Eligibility criteria
Inclusion Criteria: Short Stature Group 1. 30 boys between 6-11 years of age 2. Prepubertal 3. Short stature (height ≤ -2SDS) due to either GH deficiency or idiopathic 4. Stable treatment of other pituitary hormone deficiencies 5. Naïve to GH therapy, or GH discontinued at least 6 months prior to study Normal Stature Group 1. 15 boys between 6-11 years of age 2. Prepubertal 3. Normal height (10th to 90th%) Exclusion Criteria: 1. Actively growing brain tumors 2. Chronic medical conditions that could affect study outcomes 3. Long-term steroid use 4. Intense regular physical training programs or organized team sports
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'CASE_CONTROL', 'timePerspective': 'PROSPECTIVE'}, 'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Serum/plasma will be obtained.'}, 'enrollmentInfo': {'count': 45, 'type': 'ESTIMATED'}}
Updated at
2024-03-27

1 organization

1 product

2 indications

Organization
Nemours Children's Clinic
Product
Somatropin
Indication
Growth Hormone Deficiency
Indication
Idiopathic Short Stature