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

Description

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.

Conditions

Growth Disorders, Growth Failure, Growth Hormone Treatment, Growth

Study Overview

Study Details

Study overview

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.

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

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

Condition
Growth Disorders
Intervention / Treatment

-

Contacts and Locations

New York

Northwell Health, New York, New York, United States, 11042

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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

Ages Eligible for Study

5 Years to 15 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Northwell Health,

Benjamin U. Nwosu, MD, PRINCIPAL_INVESTIGATOR, NORTHWELL HEALTH, INC.

Study Record Dates

2025-12-10