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Growth Hormone and Chromosome 18q- and Abnormal Growth

This study has been completed.
Sponsor:
Collaborators:
South Texas Veterans Health Care System
Genentech, Inc.
Information provided by (Responsible Party):
The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier:
NCT00134420
First received: August 22, 2005
Last updated: August 4, 2016
Last verified: August 2016
  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
Loss of Chromosome 18q
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: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Growth Hormone Trial for Children With 18q- and Abnormal Growth

Resource links provided by NLM:


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

Enrollment: 20
Study Start Date: February 2001
Study Completion Date: June 2005
Primary Completion Date: June 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Growth Hormone Treatment
Arginine and Clonidine Stimulation Testing, Growth Factors Laboratory Testing, and Neuropsychological Testing was done 1st for eligibility and this group received GH (growth hormone) (Nutropin AQ) 0.3 mgs per kg per week (standard dosing for GH)immediately after randomization
Drug: Nutropin AQ
Growth Hormone (Nutropin AQ) treatment given to Group 1 immediately Growth Hormone (Nutropin AQ) treatment given to Group 2 after one year observation
Other Name: Growth Hormone (Nutropin AQ)
Procedure: Arginine and Clonidine Stimulation Testing
This testing was done to determine growth hormone status prior to starting treatment.
Procedure: Growth Factors Laboratory Testing
This involved assessment of growth factors such as IGF#1 before treatment was initiated.
Procedure: Neuropsychological Testing
This testing was done prior to treatment and at the end of treatment.
GH treatment delayed by one year
Arginine and Clonidine Stimulation Testing, Growth Factors Laboratory Testing, and Neuropsychological Testing was done first for eligibility and this group received growth hormone (Nutropin AQ) 0.3 mgs per kg per week (standard dosing for GH)after one year of observation
Procedure: Arginine and Clonidine Stimulation Testing
This testing was done to determine growth hormone status prior to starting treatment.
Procedure: Growth Factors Laboratory Testing
This involved assessment of growth factors such as IGF#1 before treatment was initiated.
Procedure: Neuropsychological Testing
This testing was done prior to treatment and at the end of treatment.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 18 Years   (Child, Adult)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, Inc.
Investigators
Principal Investigator: Daniel E. Hale, M.D. The University of Texas Health Science Center at San Antonio
  More Information

Responsible Party: The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT00134420     History of Changes
Other Study ID Numbers: 300-C07 
Study First Received: August 22, 2005
Last Updated: August 4, 2016
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
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
Endocrine System Diseases
Hormones
Mitogens
Clonidine
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents

ClinicalTrials.gov processed this record on December 09, 2016