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

Growth Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06103513
Study type Interventional
Source Northwell Health
Contact Jennifer Apsan, MD
Phone 516-472-3750
Email japsan@northwell.edu
Status Recruiting
Phase Phase 3
Start date December 10, 2023
Completion date December 10, 2025
View Details
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