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NCT Number: NCT04020913

Skeletal Muscle Effects of GH in Boys

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.

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Key information

Conditions

Growth Hormone Deficiency Bone Diseases Bone Diseases, Developmental Bone Diseases, Endocrine Brain Diseases Central Nervous System Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dwarfism Dwarfism, Pituitary Endocrine System Diseases Genetic Diseases, Inborn Hypopituitarism Hypothalamic Diseases Idiopathic Short Stature Musculoskeletal Diseases Nervous System Diseases Pituitary Diseases

Age range

6 year–11 year

Sex eligibility

Male

Study type

Observational

Primary location

Nemours Children's Clinic

Jacksonville, Florida, 32207, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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 criteria

  • 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

Treatment and study plan

Somatropin injection

Drug

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

Other names: Recombinant Growth Hormone, Norditropin

Primary outcomes

  1. 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

Secondary outcomes

  1. Skeletal muscle power (Watts)

    Time frame: 12 months

    Lower extremity power will be assessed by vertical jump performed using a Power time mat

  2. Muscle agility (seconds)

    Time frame: 12 months

    Muscle agility will be assessed by a timed shuttle run

  3. Muscle endurance

    Time frame: 12 months

    Upper body muscular endurance will be assessed using a modified push up test for repetitions

  4. Lean body mass accrual

    Time frame: 12 months

    Assessed by dual energy x-ray absorptiometry (DEXA) scan of the whole body

  5. Bone mineral density

    Time frame: 12 months

    Assessed by DEXA scan of the lumbar spine and whole body

  6. Resting energy expenditure

    Time frame: 12 months

    Indirect calorimetry will be performed after overnight fast

Sponsors and collaborators

Lead sponsor

Nemours Children's Clinic

Other

Collaborators

  • Novo Nordisk A/S

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Jul 16, 2019
Registry last updated
Nov 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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