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Randomized Clinical Trial of Two Different Initial Growth Hormone Doses in Children
Sponsor: Northwell Health
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.
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
Key Details
Gender
All
Age Range
5 Years - 15 Years
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2023-12-10
Completion Date
2028-01-05
Last Updated
2026-10-13
Healthy Volunteers
Yes
Interventions
Somatropin
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.
Locations (1)
Northwell Health
New York, New York, United States