An observational study in Growth Hormone Deficiency and Idiopathic Short Stature, sponsored by Nemours Children's Clinic. Completed at 1 site in United States. Open to male participants aged 6 Years to 11 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-11-04.
Sponsored by Nemours Children's Clinic · Observational
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.
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.
Prepubertal boys with short stature defined as a height ≤-2 SDS with either GH deficiency (i.e., peak GH responses to pharmacologic stimuli \<10ng/ml) or idiopathic short stature (i.e., normal GH, no identifiable pathology) will be studied.
Normally Statured Boys: A group of 15 healthy, normally statured (between 10th- 90th %), age-matched boys not on somatropin, preferably siblings (although not exclusively) will be studied similarly.
Short Stature Group
Normal Stature Group
Exclusion Criteria:
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.
Drug: Somatropin injection
A group of 15 healthy, normally statured (between 10th- 90th %), age-matched boys not on Growth Hormone replacement, preferably siblings (although not exclusively), will be recruited to serve as healthy controls.
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
Also known as: Recombinant Growth Hormone, Norditropin
Skeletal muscle strength (Newtons)
Upper and lower body muscle strength will be assessed using a handheld dynamometer for manual muscle testing of peak force
Time frame: 12 months
Skeletal muscle power (Watts)
Lower extremity power will be assessed by vertical jump performed using a Power time mat
Time frame: 12 months
Muscle agility (seconds)
Muscle agility will be assessed by a timed shuttle run
Time frame: 12 months
Muscle endurance
Upper body muscular endurance will be assessed using a modified push up test for repetitions
Time frame: 12 months
Lean body mass accrual
Assessed by dual energy x-ray absorptiometry (DEXA) scan of the whole body
Time frame: 12 months
Bone mineral density
Assessed by DEXA scan of the lumbar spine and whole body
Time frame: 12 months
Resting energy expenditure
Indirect calorimetry will be performed after overnight fast
Time frame: 12 months
Plan to share: No
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This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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Nemours Children's Clinic