Growth Hormone DeficiencyNCT04020913
Skeletal Muscle Effects of GH in Boys
An observational study of Growth Hormone Deficiency and Idiopathic Short Stature, run by Nemours Children's Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 11 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Growth Hormone Deficiency, Idiopathic Short Stature
- What is being tested?
- Somatropin injection
- Type of treatment
- Injection or infusion
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jul 2019to 30 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 11 years
- Men only
- Healthy volunteers accepted
- Child
Study population: 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.
Who may be able to join
- 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
Show all 10Show fewer
- Normal Stature Group
- 15 boys between 6-11 years of age
- Prepubertal
- Normal height (10th to 90th%)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Nemours Children's Clinic
Jacksonville, Florida, 32207
About this study
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
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.
Read the 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.
- Being tested
- Somatropin injection
- Keywords
- GH, muscle strength, prepubertal, boys, short stature, GH treatment, muscle agility
- Medical subject headings
- Dwarfism, Pituitary, Dwarfism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Somatropin injectionDrug
Also called Recombinant Growth Hormone, Norditropin
Boys with short stature will be studied for measures of:
- skeletal muscle strength, power, and endurance
- muscle agility
- lean body mass accrual
- bone mineral density and resting energy expenditure before and after 6 months and 12 months of GH administration
| Study group | Role | What they receive |
|---|---|---|
| Short Stature Boys | 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. Receives: Drug: Somatropin injection | |
| Normally Statured Boys | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skeletal muscle strength (Newtons)
Upper and lower body muscle strength will be assessed using a handheld dynamometer for manual muscle testing of peak force
Measured: 12 months
Secondary outcomes (6)
Skeletal muscle power (Watts)
Lower extremity power will be assessed by vertical jump performed using a Power time mat
Measured: 12 months
Muscle agility (seconds)
Muscle agility will be assessed by a timed shuttle run
Measured: 12 months
Muscle endurance
Upper body muscular endurance will be assessed using a modified push up test for repetitions
Measured: 12 months
Lean body mass accrual
Assessed by dual energy x-ray absorptiometry (DEXA) scan of the whole body
Measured: 12 months
Bone mineral density
Assessed by DEXA scan of the lumbar spine and whole body
Measured: 12 months
Resting energy expenditure
Indirect calorimetry will be performed after overnight fast
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2019
- Study start22 Jul 2019
- Primary completion30 Sep 2025
- Study completion30 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Growth Hormone DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nemours Children's Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Novo Nordisk A/S
- Responsible party
- Principal investigator, Nelly Mauras, Nemours Children's Clinic
- Investigators
- Nelly Mauras, MD, Principal investigator, Nemours Children's Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04020913
- Sponsor's protocol ID
- #19-09
- Other IDs
- U111112218502
- Status last verified
- Nov 2025
- First submitted
- 24 May 2019
- Last updated
- 4 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04020913
- Acronym / sponsor ID
- #19-09
- Keywords
- GH, muscle strength, prepubertal, boys, short stature, GH treatment, muscle agility
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Nemours Children's ClinicUniversity, hospital or other
- Collaborators
- Novo Nordisk A/S
- Study start
- 22 Jul 2019 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 30 Oct 2025 (actual)
- First posted
- 16 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Short Stature Boys | – | Drug: Somatropin injectionPrepubertal 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. |
| Normally Statured Boys | – | –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. |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- 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.
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Somatropin injectionAlso: Recombinant Growth Hormone, NorditropinBoys 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 | Drug | Short Stature Boys |
Primary outcome
Skeletal muscle strength (Newtons)
Time frame: 12 months
Upper and lower body muscle strength will be assessed using a handheld dynamometer for manual muscle testing of peak force
6 secondary outcomes
Skeletal muscle power (Watts)
Time frame: 12 months
Muscle agility (seconds)
Time frame: 12 months
Muscle endurance
Time frame: 12 months
Lean body mass accrual
Time frame: 12 months
Bone mineral density
Time frame: 12 months
Resting energy expenditure
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2025.
- Individual participant dataSharing planned: No
Related trials for Growth Hormone Deficiency
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Randomized Clinical Trial of Two Different Initial Growth Hormone Doses in Children
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RecruitingPhase 3
Growth Hormone Replacement Therapy in Veterans With Mild Traumatic Brain Injury (mTBI) and Adult Growth Hormone Deficiency (AGHD)
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Enrolling by invitationObservational study
Influence of Adherence to Growth Hormone Therapy (GHT) With Norditropin® on Near Final Height in Patients With Growth Hormone Deficiency (GHD) and Born Small for Gestational Age (SGA)
Growth Hormone Deficiency in Children, Born Small for Gestational Age
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nelly Mauras, MD principal investigator
Nemours Children's Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Growth Hormone Deficiency and Idiopathic Short Stature, run by Nemours Children's Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skeletal muscle strength (Newtons) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2025.