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Individualized, Target-Driven Treatment Of Children With Idiopathic Short Stature | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Individualized, Target-Driven Treatment Of Children With Idiopathic Short Stature

A Four Year Open Label Multi Center Randomized Two Arm Study Of Genotropin In Idiopathic Short Stature Patients: Comparing An Individualized, Target Driven Treatment Regimen To Standard Dosing Of Genotropin

NCT00396097•Pfizer

View on ClinicalTrials.gov

Summary

To demonstrate that an individualized, formula-based Genotropin regimen for children with Idiopathic Short Stature will lead to a targeted height gain (to reach the target of 10th percentile (%), or -1.3 SDS) during 24 months of treatment. The endpoint at 4 years is to explore treatment efficiency over four years of two formula-based dose regimens (sub-arms) compared to standard treatment

Eligibility

Age

3 - 10 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Prepubertal children with bone ages between 3 and 10 years of age for males and 3 and 9 years of age for females
•Naive to Growth Hormone treatment

Exclusion Criteria

•Abnormal karyotype. Small Gestational Age and Skeletal dysplasia.

Locations (43)

Arkansas Children's Hospital

Little Rock, Alaska, United States

Arkansas Children's Hospital

Little Rock, Arkansas, United States

Children's Hospital of Los Angeles

Los Angeles, California, United States

Rady Children's Hospital - San Diego

San Diego, California, United States

Pediatric Endocrinology of San Diego Medical Group Incorporated

San Diego, California, United States

Childrens Hospital Colorado

Aurora, Colorado, United States

Memorial Pediatric Specialty Clinic

Colorado Springs, Colorado, United States

Pediatric Endocrine Associates

Greenwood Village, Colorado, United States

Pediatric Endocrine Associates at The Longmont Clinic

Longmont, Colorado, United States

Joe DiMaggio Children's Hospital

Hollywood, Florida, United States

Key Dates

Start Date

December 1, 2006

Primary Completion Date

August 1, 2012

Completion Date

August 1, 2012

Last Updated

April 5, 2016

Enrollment

316

ACTUAL participants

Conditions

Idiopathic Short Stature

Interventions

Genotropin

DRUG

Genotropin

DRUG

A Study of the Genetic Basis of Response to Growth Hormone Treatment in Children With Idiopathic Short Stature

NCT05894876

Idiopathic Short Stature

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COMPLETED

Skeletal Muscle Effects of GH in Boys

NCT04020913

Growth Hormone DeficiencyIdiopathic Short Stature

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WITHDRAWNPHASE4

Predictive Value of the Insulin-like Growth Factor-1 (IGF-1) Generation Test for the Growth Response to Growth Hormone Treatment (PRED-IGF)

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 5, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.