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Anterior Pituitary Hormone Replacement in Traumatic Brain Injury

This study is currently recruiting participants.
Verified April 2013 by The University of Texas, Galveston
Sponsor:
Collaborator:
The Moody Foundation
Information provided by (Responsible Party):
The University of Texas, Galveston
ClinicalTrials.gov Identifier:
NCT00957671
First received: August 10, 2009
Last updated: April 9, 2013
Last verified: April 2013
History of Changes
  Purpose

Fifteen to twenty percent of adults who suffer a traumatic brain injury (TBI) that requires hospitalization and rehabilitation have been found to have growth hormone (GH) deficiency by GH stimulation testing. Moreover, abnormalities have also been established for the cortisol and thyroid axis. The hypothesis of this proposal is that hormone replacement in TBI patients with documented abnormalities in the GH, thyroid, or cortisol axis will improve muscle function, body composition, aerobic capacity (GH) and tests of neuropsychologic function (GH, thyroid, cortisol).


Condition Intervention Phase
Growth Hormone Deficiency
Traumatic Brain Injury
 Drug: Human Growth Hormone
Drug: Placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Anterior Pituitary Hormone Replacement in Traumatic Brain Injury

Resource links provided by NLM:

Drug Information available for: Somatropin
U.S. FDA Resources

Further study details as provided by The University of Texas, Galveston:

Primary Outcome Measures:
  • Determine the effect of recombinant human growth hormone (rhGH) replacement on neuropsychologic function in individuals with growth hormone deficiency following traumatic brain injury [ Time Frame: One year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Determine the effect of recombinant human growth hormone (rhGH) replacement on muscle function function in individuals with growth hormone deficiency following traumatic brain injury [ Time Frame: One year ] [ Designated as safety issue: Yes ]
  • Determine the effect of recombinant human growth hormone (rhGH) replacement on body composition in individuals with growth hormone deficiency following traumatic brain injury [ Time Frame: One year ] [ Designated as safety issue: Yes ]
  • Determine the effect of recombinant human growth hormone (rhGH) replacement on aerobic capacity in individuals with growth hormone deficiency following traumatic brain injury [ Time Frame: One year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 400
Study Start Date: November 2003
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Human Growth Hormone
Growth hormone administered daily for one year
 Drug: Human Growth Hormone
200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total)
Placebo Comparator: Placebo Drug: Placebo
Inert agent given in same manner as active drug for control purposes

Detailed Description:

This protocol is designed to screen and detect evidence of pituitary hormone deficiency in adults following traumatic brain injury. Treatment period for thyroid or cortisol deficiency will be six months. Growth hormone deficiency will be replaced for a period of one year followed by a second year of open label treatment to allow individuals in the placebo group an opportunity to demonstrate a response to hormone replacement. Subject will not be screened until at least one year following brain injury to allow for natural recovery of hormone function.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients aged 21 and older.
  • Documented moderate to severe traumatic brain injury at least one year post injury.

Exclusion Criteria:

  • The only absolute exclusionary medication will be an anticoagulant (Coumadin) because of the risk of bleeding during the possible muscle biopsy procedure and daily injections of rhGH in the GH arm of the study.
  • Any subject with a history of hepatitis or a 3-fold elevation of liver function tests (Alk phos, alanine aminotransferase (ALT), aspartate aminotransferase (AST)). We are uncertain of the effects of hormone replacement such as rhGH on the liver, so we will exclude any subjects with hepatitis. This exclusion applies only to subjects who would be enrolled in the GH arm of the study.
  • Subjects who are deficient in cortisol or thyroid at screening will be excluded until hormone abnormalities have been corrected.
  • Subjects with chronic pain who are being managed with narcotics will be excluded as the effects of central nervous system depressants may interfere with study test results.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00957671

Contacts
Contact: Jack Foreman (800) 852-4769 ext 448 jforeman@tlcgalveston.org
Contact: Charles R. Gilkison, RN, MSN (409) 772-2065 cgilkiso@utmb.edu

Locations
United States, Texas
The University of Texas Medical Branch at Galveston Recruiting
Galveston, Texas, United States, 77555
Contact: Randall J Urban, M.D.     409-772-1176     rurban@utmb.edu    
Contact: Charles R Gilkison, RN,MSN     (409) 772-2065     cgilkiso@utmb.edu    
Transitional Learning Center Recruiting
Galveston, Texas, United States, 77550
Contact: Brent Masel, M.D.     409-797-1411     bmasel@tlc-galveston.org    
Contact: Dennis Zgaljardic, Ph.D.     (409) 797-1416     dzaljardic@tlc-galveston.org    
Sponsors and Collaborators
The University of Texas, Galveston
The Moody Foundation
Investigators
Principal Investigator: Randall J Urban, M.D. The University of Texas Medical Branch at Galveston
  More Information

No publications provided

Responsible Party: The University of Texas, Galveston
ClinicalTrials.gov Identifier: NCT00957671     History of Changes
Other Study ID Numbers: 03-034
Study First Received: August 10, 2009
Last Updated: April 9, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by The University of Texas, Galveston:
TBI
Traumatic Brain injury
Growth hormone deficiency
Anterior pituitary hormone

Additional relevant MeSH terms:
Dwarfism, Pituitary
Brain Injuries
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
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013