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

Northwell Health

Status and phase: Enrolling; Phase 3

Conditions: Growth Disorders; Growth Hormone Treatment; Growth Failure; Growth

Treatments: Drug: Somatropin

Study type: Interventional

Funder types: Other

Identifiers

NCT06103513

23-0027

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 5 to 15 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Arm 1: Growth hormone 0.2 mg/kg/week

Active Comparator group

Description:

Twenty-five subjects will initiate rhGH therapy at 0.2 mg/kg/week for the first 12 months of treatment

Treatment:

Drug: Somatropin

Arm 2: Growth hormone 0.3 mg/kg/week

Active Comparator group

Description:

Twenty-five subjects will initiate rhGH therapy at 0.3 mg/kg/week for the first 12 months of treatment

Treatment:

Drug: Somatropin