Brief Title
Skeletal Muscle Effects of GH in Boys
Official Title
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
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 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.
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 recruited. Subjects will have a battery of studies to assess skeletal muscle
strength, agility, power and endurance, as well as assessment of body composition and energy
expenditure before and after GH administration. GH (Somatropin) treatment at standard doses
will be given as daily injections at bedtime. Subjects will be followed at three-month
intervals per the clinical routine, when anthropometric measurements will be obtained.
Baseline studies will be repeated at 6 and 12 months from initiation of treatment, each
patient will serve as his own control pre and post GH.
A group of normally statured healthy boys will have the same testing as the study patients
but without GH treatment to assess the impact of natural growth on the muscle measures above.
Study Type
Observational
Primary Outcome
Skeletal muscle strength (Newtons)
Secondary Outcome
Skeletal muscle power (Watts)
Condition
Growth Hormone Deficiency
Intervention
Somatropin injection
Study Arms / Comparison Groups
Short Stature Boys
Description: Prepubertal boys with short stature defined as a height ≤-2 SDS with either GH deficiency (defined as peak GH responses to pharmacologic stimuli <10ng/ml) or idiopathic short stature (i.e., no identifiable pathology) will be studied pre and post 12 months of GH therapy.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
45
Start Date
July 22, 2019
Completion Date
July 21, 2025
Primary Completion Date
July 21, 2023
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
Gender
Male
Ages
6 Years - 11 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Nelly Mauras, MD, 904-697-3674, [email protected]
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT04020913
Organization ID
#19-09
Secondary IDs
U111112218502
Responsible Party
Sponsor
Study Sponsor
Nemours Children's Clinic
Collaborators
Novo Nordisk A/S
Study Sponsor
Nelly Mauras, MD, Principal Investigator, Nemours Children's Clinic
Verification Date
April 2022