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Skeletal Muscle Effects of GH in Boys

NCT04020913 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 45

Last updated 2025-11-04

No results posted yet for this study

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.

Conditions

  • Growth Hormone Deficiency
  • Idiopathic Short Stature

Interventions

DRUG

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

Sponsors & Collaborators

Principal Investigators

  • Nelly Mauras, MD · Nemours Children's Clinic

Eligibility

Min Age
6 Years
Max Age
11 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-07-22
Primary Completion
2025-09-30
Completion
2025-10-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04020913 on ClinicalTrials.gov