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

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.

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.

Eligibility

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.