Randomized Clinical Trial of Two Different Initial Growth Hormone Doses in Children

December 12, 2023 updated by: Northwell Health

A Randomized Clinical Trial of Two Different Initial Growth Hormone Doses in Children With Growth Hormone Deficiency in the First Year of Treatment

A prospective, randomized, open-label single-blinded study of 50 subjects with growth hormone deficiency, ages 5 to 15 years in which 25 subjects will initiate rhGH therapy at 0.3mg/kg/week and the remaining 25 subjects will initiate their rhGH treatment at 0.2 mg/kg/week for the first 12 months of treatment. Safety parameters, height velocity, and adult height prediction by bone age determination will be assessed at 4-month intervals for 1 year following the initiation of rhGH therapy.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Investigators propose a prospective randomized, open-label single-blinded study of 50 subjects with growth hormone deficiency, ages 5 to 15 years. 25 subjects will be randomized to initiate a dose of 0.3 mg/kg/week (0.28-0.32 mg/kg/week) and the remaining 25 subjects will initiate their rhGH treatment at 0.2 mg/kg/week (0.18-0.22 mg/kg/week) for the first 12 months of treatment. Safety parameters, height velocity, and adult height prediction by bone age determination will be assessed at 4-month intervals for 1 year following the initiation of rhGH therapy.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • New York
      • New York, New York, United States, 11042
        • Recruiting
        • Northwell Health
        • Contact:
        • Contact:
        • Principal Investigator:
          • Benjamin Nwosu, MD
        • Sub-Investigator:
          • Jennifer Apsan, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Provision of signed and dated informed consent form
  2. Stated willingness to comply with all study procedures and availability for the duration of the study
  3. Male or female, aged 5-15 years
  4. In good general health as evidenced by medical history or diagnosed with growth hormone deficiency
  5. Ability to take subcutaneous GH injections nightly

Exclusion Criteria:

Subjects will be excluded if they have GH resistance, or syndromic short stature such as Prader Willi syndrome and Turner syndrome. Patients will also be excluded if they have active malignancies, or systemic illnesses such as heart failure, kidney failure, or liver failure.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm 1: Growth hormone 0.2 mg/kg/week
Twenty-five subjects will initiate rhGH therapy at 0.2 mg/kg/week for the first 12 months of treatment
Drug: Somatropin
The treatment of children with subcutaneous recombinant human growth hormone (rhGH) is the current gold standard of care for children with diagnosed GHD. This study will serve only to investigate the optimal dose of treatment in the first year of treatment with rhGH.
Other Names:
  • Norditropin, Nutropin AQ, Genotropin, Zomacton, Humatrope, Omnitrope.
Active Comparator: Arm 2: Growth hormone 0.3 mg/kg/week
Twenty-five subjects will initiate rhGH therapy at 0.3 mg/kg/week for the first 12 months of treatment
Drug: Somatropin
The treatment of children with subcutaneous recombinant human growth hormone (rhGH) is the current gold standard of care for children with diagnosed GHD. This study will serve only to investigate the optimal dose of treatment in the first year of treatment with rhGH.
Other Names:
  • Norditropin, Nutropin AQ, Genotropin, Zomacton, Humatrope, Omnitrope.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Annualized Growth Velocity (GV) in the first year after treatment
Time Frame: I year
Height (cm) at 0- month visit; height (cm) at 12-month visit
I year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IGF1- 0,4,8,12 months
Time Frame: 12 Months
IGF-1 will be collected at timepoints - 0,4,8,12 months
12 Months
IGFBP3 - 0,4,8,12 months
Time Frame: 12 Months
IGFBP3 will be collected at timepoints - 0,4,8,12 months
12 Months
HbA1c - 4,8,12 months
Time Frame: 12 Months
HbA1c will be collected at timepoints 4,8,12 months
12 Months
Total T4 or Free T4 - 0,12 months
Time Frame: 12 Months
Total T4 or Free T4 will be collected at timepoints 0,12 months
12 Months
TSH - 0, 12 months
Time Frame: 12 Months
TSH will be collected at timepoints 0, 12 months
12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwell Health

Investigators

  • Principal Investigator: Benjamin U. Nwosu, MD, Northwell Health, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 10, 2023

Primary Completion (Estimated)

June 10, 2025

Study Completion (Estimated)

December 10, 2025

Study Registration Dates

First Submitted

October 17, 2023

First Submitted That Met QC Criteria

October 25, 2023

First Posted (Actual)

October 26, 2023

Study Record Updates

Last Update Posted (Estimated)

December 13, 2023

Last Update Submitted That Met QC Criteria

December 12, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-0027

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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