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Growth Hormone Replacement Therapy in Veterans With Mild Traumatic Brain Injury (mTBI) and Adult Growth Hormone Deficiency (AGHD)
Sponsor: VA Office of Research and Development
Summary
The purpose of this study is to determine whether growth hormone replacement therapy (GHRT) is effective versus placebo in the improvement of Quality of Life in patients with adult growth hormone deficiency (AGHD) and mild traumatic brain injury (mTBI).
Official title: CSP #2018 - Growth Hormone Replacement Therapy in Veterans With Mild Traumatic Brain Injury (mTBI) and Adult Growth Hormone Deficiency (AGHD)
Key Details
Gender
All
Age Range
21 Years - 55 Years
Study Type
INTERVENTIONAL
Enrollment
172
Start Date
2025-01-13
Completion Date
2029-09-30
Last Updated
2026-05-15
Healthy Volunteers
No
Interventions
Somatropin
Participants (n=172) will be randomized in a 1:1 ratio to rhGH (n=86) versus placebo (n=86) for six months, stratified by participating site. Both study participants and the study team will be blinded to treatment assignment. All participants will complete in-clinic follow-ups at Days 14, 40, 65, and 90 (3 months) and at day 180 (6 months). The primary outcome will be the mean difference in QoL-AGHDA scores between treatment arms at 6 months follow-up. Patients will discontinue the study intervention at 6 months, and will be followed-up two weeks subsequent, in order to assure patient safety and wellness, and to ensure maximal facilitation of patient transition back into routine care.
Placebo
Participants (n=172) will be randomized in a 1:1 ratio to rhGH (n=86) versus placebo (n=86) for six months, stratified by participating site. Both study participants and the study team will be blinded to treatment assignment. All participants will complete in-clinic follow-ups at Days 14, 40, 65, and 90 (3 months) and at day 180 (6 months). The primary outcome will be the mean difference in QoL-AGHDA scores between treatment arms at 6 months follow-up. Patients will discontinue the study intervention at 6 months, and will be followed-up two weeks subsequent, in order to assure patient safety and wellness, and to ensure maximal facilitation of patient transition back into routine care.
Locations (17)
Birmingham VA Medical Center, Birmingham, AL
Birmingham, Alabama, United States
Phoenix VA Health Care System, Phoenix, AZ
Phoenix, Arizona, United States
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, United States
VA San Diego Healthcare System, San Diego, CA
San Diego, California, United States
Rocky Mountain Regional VA Medical Center, Aurora, CO
Aurora, Colorado, United States
Washington DC VA Medical Center, Washington, DC
Washington D.C., District of Columbia, United States
Atlanta VA Medical and Rehab Center, Decatur, GA
Decatur, Georgia, United States
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, United States
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, United States
Kansas City VA Medical Center, Kansas City, MO
Kansas City, Missouri, United States
Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE
Omaha, Nebraska, United States
Salisbury W.G. (Bill) Hefner VA Medical Center, Salisbury, NC
Salisbury, North Carolina, United States
Oklahoma City VA Medical Center, Oklahoma City, OK
Oklahoma City, Oklahoma, United States
VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
Dallas, Texas, United States
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, United States
South Texas Health Care System, San Antonio, TX
San Antonio, Texas, United States
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, United States