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Anterior Pituitary Hormone Replacement in Traumatic Brain Injury

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ClinicalTrials.gov Identifier: NCT00957671
Recruitment Status : Completed
First Posted : August 12, 2009
Last Update Posted : May 12, 2016
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Growth Hormone Deficiency Traumatic Brain Injury Drug: Human Growth Hormone Drug: Placebo Phase 4

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Anterior Pituitary Hormone Replacement in Traumatic Brain Injury
Study Start Date : November 2003
Primary Completion Date : October 2015
Study Completion Date : October 2015


Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00957671


Locations
United States, Texas
Transitional Learning Center
Galveston, Texas, United States, 77550
The University of Texas Medical Branch at Galveston
Galveston, Texas, United States, 77555
Sponsors and Collaborators
The University of Texas Medical Branch, Galveston
The Moody Foundation
Investigators
Principal Investigator: Randall J Urban, M.D. The University of Texas Medical Branch at Galveston
More Information

Responsible Party: The University of Texas Medical Branch, Galveston
ClinicalTrials.gov Identifier: NCT00957671     History of Changes
Other Study ID Numbers: 03-034
First Posted: August 12, 2009    Key Record Dates
Last Update Posted: May 12, 2016
Last Verified: May 2016

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

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Brain Injuries, Traumatic
Pituitary Diseases
Endocrine System Diseases
Dwarfism, Pituitary
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Hypothalamic Diseases
Dwarfism
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine
Hypopituitarism
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs