Effect of Growth Hormone in Children With Growth Hormone Deficiency

Novo Nordisk A/S173 enrolled

Overview

This trial is conducted in the United States of America (USA). The purpose of the trial is to compare the effect of Norditropin® using different dosing regimens in children suspected of growth hormone deficiency.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

173

Conditions

Growth Hormone Disorder Growth Hormone Deficiency in Children Growth Disorder Idiopathic Short Stature

Interventions

somatropinDRUG

Eligibility

Sex: ALLMin age: 3 YearsMax age: 15 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Clinically suspected GHD * Height \< -2.0 SDS * Serum IGF-I less than or equal to -1.0 SDS * Bone age less than or equal to 9 years for boys and less than or equal to 7 years for girls. * Puberty Tanner Stage I Exclusion Criteria: * Previous use of growth hormone * Growth retardation attributable to causes other than GHD (e.g. inborn errors of metabolism, primary bone disease, chromosomal disorders, etc.) * Intrauterine growth retardation: birth weight \< 3rd percentile. * Administration of other growth-altering medications. * Evidence of any malignancy or intracranial tumors.

Locations (40)

Outcomes

Primary Outcomes

Change in height standard deviation score

Time frame: 24 month

Secondary Outcomes

IGF-I

IGFBP-3

free IGF-I

Data from ClinicalTrials.gov

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