NCT00134420

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Feb 2001

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2001

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 22, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 24, 2005

Completed
Last Updated

August 8, 2016

Status Verified

August 1, 2016

Enrollment Period

4.3 years

First QC Date

August 22, 2005

Last Update Submit

August 4, 2016

Conditions

Loss of Chromosome 18qGrowth Hormone Deficiency

Keywords

Growth HormoneChromosomes, Human, Pair 18Child

Outcome Measures

Primary Outcomes (1)

  • growth rates 12-15 months after treatment begins

Secondary Outcomes (1)

  • performance IQ scores 12-15 months after treatment begins

Study Arms (2)

Growth Hormone Treatment

ACTIVE COMPARATOR

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 AQProcedure: Arginine and Clonidine Stimulation TestingProcedure: Growth Factors Laboratory TestingProcedure: Neuropsychological Testing

GH treatment delayed by one year

OTHER

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 TestingProcedure: Growth Factors Laboratory TestingProcedure: Neuropsychological Testing

Interventions

Nutropin AQDRUG

Growth Hormone (Nutropin AQ) treatment given to Group 1 immediately Growth Hormone (Nutropin AQ) treatment given to Group 2 after one year observation

Also known as: Growth Hormone (Nutropin AQ)
Growth Hormone Treatment
Arginine and Clonidine Stimulation TestingPROCEDURE

This testing was done to determine growth hormone status prior to starting treatment.

GH treatment delayed by one yearGrowth Hormone Treatment
Growth Factors Laboratory TestingPROCEDURE

This involved assessment of growth factors such as IGF#1 before treatment was initiated.

GH treatment delayed by one yearGrowth Hormone Treatment
Neuropsychological TestingPROCEDURE

This testing was done prior to treatment and at the end of treatment.

GH treatment delayed by one yearGrowth Hormone Treatment

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • Children previously on growth hormone therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229-3900, United States

Location

MeSH Terms

Conditions

Dwarfism, Pituitary

Interventions

Growth HormoneArginineNeuropsychological Tests

Condition Hierarchy (Ancestors)

DwarfismBone Diseases, DevelopmentalBone DiseasesMusculoskeletal DiseasesBone Diseases, EndocrineHypopituitarismPituitary DiseasesHypothalamic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormones, AnteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsAmino Acids, BasicAmino AcidsAmino Acids, DiaminoAmino Acids, EssentialPsychological TestsBehavioral Disciplines and Activities

Study Officials

  • Daniel E. Hale, M.D.

    The University of Texas Health Science Center at San Antonio

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 22, 2005

First Posted

August 24, 2005

Study Start

February 1, 2001

Primary Completion

June 1, 2005

Study Completion

June 1, 2005

Last Updated

August 8, 2016

Record last verified: 2016-08

Locations

US(1)