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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Growth Disorders, Growth Failure, Growth Hormone Treatment, Growth

Intervention / Treatment
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* Drug: Somatropin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm 1: Growth hormone 0.2 mg/kg/week<br>Twenty-five subjects will initiate rhGH therapy at 0.2 mg/kg/week for the first 12 months of treatment | Drug: Somatropin<br>* 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.<br>* Other names: Norditropin, Nutropin AQ, Genotropin, Zomacton, Humatrope, Omnitrope.;|
| Active Comparator: Arm 2: Growth hormone 0.3 mg/kg/week<br>Twenty-five subjects will initiate rhGH therapy at 0.3 mg/kg/week for the first 12 months of treatment | Drug: Somatropin<br>* 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.<br>* Other names: Norditropin, Nutropin AQ, Genotropin, Zomacton, Humatrope, Omnitrope.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Annualized Growth Velocity (GV) in the first year after treatment | 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 | IGF-1 will be collected at timepoints - 0,4,8,12 months | 12 Months | 
| IGFBP3 - 0,4,8,12 months | IGFBP3 will be collected at timepoints - 0,4,8,12 months | 12 Months | 
| HbA1c - 4,8,12 months | HbA1c will be collected at timepoints 4,8,12 months | 12 Months | 
| Total T4 or Free T4 - 0,12 months | Total T4 or Free T4 will be collected at timepoints 0,12 months | 12 Months | 
| TSH - 0, 12 months | TSH will be collected at timepoints 0, 12 months | 12 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Growth Hormone