Skeletal Muscle Effects of GH in Boys

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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