A Randomized Clinical Trial of Two Different Initial Growth Hormone Doses in Children With Growth Hormone Deficiency in the First Year of Treatment
Overview
- Phase
- Phase 3
- Intervention
- Somatropin
- Conditions
- Growth Disorders
- Sponsor
- Northwell Health
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Annualized Growth Velocity (GV) in the first year after treatment
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Male or female, aged 5-15 years
- •In good general health as evidenced by medical history or diagnosed with growth hormone deficiency
- •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.
Arms & Interventions
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
Intervention: Somatropin
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
Intervention: Somatropin
Outcomes
Primary Outcomes
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
Secondary Outcomes
- IGFBP3 - 0,4,8,12 months(12 Months)
- HbA1c - 4,8,12 months(12 Months)
- TSH - 0, 12 months(12 Months)
- IGF1- 0,4,8,12 months(12 Months)
- Total T4 or Free T4 - 0,12 months(12 Months)