Growth Hormone and Chromosome 18q- and Abnormal Growth

This study is ongoing, but not recruiting participants.

First Received: August 22, 2005 Last Updated: July 17, 2007 History of Changes

Sponsor:	The University of Texas Health Science Center at San Antonio
Collaborators:	South Texas Veterans Health Care System Genentech
Information provided by:	The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier:	NCT00134420

Purpose

We, the investigators at the University of Texas Health Science Center at San Antonio, want to learn if height and IQ (intelligence quotient) scores are improved by growth hormone (GH) treatment in children with chromosome 18 deletions and abnormal growth. Data from a previous study showed that growth hormone improved height in all children with 18q- and growth hormone deficiency. In addition, most of the study participants on growth hormone treatment showed an increase in IQ scores.

Condition	Intervention	Phase
Chromosome 18 Growth Hormone Deficiency	Drug: Nutropin AQ Procedure: Arginine and Clonidine Stimulation Testing Procedure: Growth Factors Laboratory Testing Procedure: Neuropsychological Testing	Phase III

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Efficacy Study
Official Title:	Growth Hormone Trial for Children With 18q- and Abnormal Growth

Resource links provided by NLM:

Genetics Home Reference related topics: pseudoachondroplasia

Drug Information available for: Somatropin Arginine Clonidine Somatotropin

U.S. FDA Resources

Further study details as provided by The University of Texas Health Science Center at San Antonio:

Primary Outcome Measures:

growth rates 12-15 months after treatment begins

Secondary Outcome Measures:

performance IQ scores 12-15 months after treatment begins

Estimated Enrollment:	20
Study Start Date:	February 2001
Estimated Study Completion Date:	June 2005

Show Detailed Description

Eligibility

Ages Eligible for Study:	up to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Diagnosis of chromosome 18 deletion (cytogenetics report)
Children with abnormal growth but who are not classically growth hormone deficient

Exclusion Criteria:

Children previously on growth hormone therapy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00134420

Locations

United States, Texas
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229-3900

Sponsors and Collaborators

The University of Texas Health Science Center at San Antonio

South Texas Veterans Health Care System

Genentech

Investigators

Principal Investigator:

Daniel E. Hale, M.D.

The University of Texas Health Science Center at San Antonio

More Information

No publications provided

Study ID Numbers:	300-C07
Study First Received:	August 22, 2005
Last Updated:	July 17, 2007
ClinicalTrials.gov Identifier:	NCT00134420 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by The University of Texas Health Science Center at San Antonio:

Growth Hormone
Chromosomes, Human, Pair 18
Child

Additional relevant MeSH terms:

Dwarfism
Bone Diseases, Endocrine
Hypothalamic Diseases
Molecular Mechanisms of Pharmacological Action
Pituitary Diseases
Physiological Effects of Drugs
Mitosis Modulators
Nervous System Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Endocrine System Diseases

Central Nervous System Diseases
Dwarfism, Pituitary
Brain Diseases
Hormones
Bone Diseases
Pharmacologic Actions
Musculoskeletal Diseases
Hypopituitarism
Bone Diseases, Developmental
Mitogens

ClinicalTrials.gov processed this record on February 08, 2010