Growth Hormone and Chromosome 18q- and Abnormal Growth

The recruitment status of this study is unknown because the information has not been verified recently.

Verified July 2007 by The University of Texas Health Science Center at San Antonio. Recruitment status was Active, not recruiting

First Received on August 22, 2005. Last Updated on 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 3

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic
Official Title:	Growth Hormone Trial for Children With 18q- and Abnormal Growth

Resource links provided by NLM:

Genetics Home Reference related topics: combined pituitary hormone deficiency isolated growth hormone deficiency metatropic dysplasia pseudoachondroplasia

Drug Information available for: Arginine Clonidine Clonidine hydrochloride Somatropin

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

ClinicalTrials.gov Identifier:	NCT00134420 History of Changes
Other Study ID Numbers:	300-C07
Study First Received:	August 22, 2005
Last Updated:	July 17, 2007
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, Pituitary
Endocrine System Diseases
Dwarfism
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine
Hypopituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Clonidine
Mitogens

Hormones
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 24, 2012