Growth Hormone Replacement Therapy in Veterans With Mild Traumatic Brain Injury (mTBI) and Adult Growth Hormone Deficiency (AGHD)
Part of paid clinical trials in Birmingham, Alabama.
- Sponsor
- VA Office of Research and Development
- Study ID
- NCT04867317
- Phase
- PHASE3
- Status
- Recruiting
Conditions
- Adult Growth Hormone Deficiency
- Mild Traumatic Brain Injury
Eligibility Criteria
- Sex
- ALL
- Age
- 21 Years - 55 Years
- Healthy Volunteers
- Not accepted
Interventions
- Somatropin — DRUGParticipants (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 — OTHERParticipants (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.
Study Details
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).
Key Dates
- Start date
- Jan 13, 2025
- Status verified
- May 2026
- Primary completion
- Feb 28, 2027
- Completion
- Sep 30, 2029
Study Design
- Enrollment
- 172 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Active Comparator: Growth Hormone Replacement TherapyRecombinant Human Growth Hormone
- Placebo Comparator: PlaceboPlacebo
Primary Outcome Measure
QoL-AGHDA (Quality of Life-Assessment of Adult Growth Hormone in Adults) [ Time Frame: 6 months ]
Central Contacts
- Deane V Walker, MHA BS AB(203) 937-3440
- Michael T Wininger, PhD(203) 932-5711
Locations (17)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Birmingham VA Medical Center, Birmingham, AL | Birmingham | Alabama | 35233-1927 | Ripu Jindal, MD Emily Schlitz, MD |
| Phoenix VA Health Care System, Phoenix, AZ | Phoenix | Arizona | 85012 | Sherman Harman, MD Steven F Werder, DO |
| VA Palo Alto Health Care System, Palo Alto, CA | Palo Alto | California | 94304-1207 | TBD TBD 000-000-0000 TBD TBD, MD 0000000000 |
| VA San Diego Healthcare System, San Diego, CA | San Diego | California | 92161-0002 | Richard L Hauger, MD Christopher Hupfeld, MD |
| Rocky Mountain Regional VA Medical Center, Aurora, CO | Aurora | Colorado | 80045-7211 | Lisa Brenner, PhD Salwa Zahalka, MD |
| Washington DC VA Medical Center, Washington, DC | Washington D.C. | District of Columbia | 20422-0001 | Sen Sabyasachi, MD |
| Atlanta VA Medical and Rehab Center, Decatur, GA | Decatur | Georgia | 30033-4004 | - |
| VA Ann Arbor Healthcare System, Ann Arbor, MI | Ann Arbor | Michigan | 48105-2303 | Richard J Auchus, MD Percival Pangilinan, MD |
| Minneapolis VA Health Care System, Minneapolis, MN | Minneapolis | Minnesota | 55417-2309 | |
| Kansas City VA Medical Center, Kansas City, MO | Kansas City | Missouri | 64128-2226 | Mariana Garcia-Touza, MD Vikas Singh, MD |
| Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE | Omaha | Nebraska | 68105-1850 | Cyrus V DeSouza, MBBS Daniel Pierce, MD |
| Salisbury W.G. (Bill) Hefner VA Medical Center, Salisbury, NC | Salisbury | North Carolina | 28144 | Robin hurley, MD Donald Mcclain, DO |
| Oklahoma City VA Medical Center, Oklahoma City, OK | Oklahoma City | Oklahoma | 73104-5007 | Calin Prodan, MD Robert Scofield, MD |
| VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX | Dallas | Texas | 75216-7167 | kyaw Soe, MD Weibin Yang, MD |
| Michael E. DeBakey VA Medical Center, Houston, TX | Houston | Texas | 77030-4211 | |
| South Texas Health Care System, San Antonio, TX | San Antonio | Texas | 78229-4404 | Devjit Tripathy, MD Gustavo Armaiz-Pena, MD |
| VA Puget Sound Health Care System Seattle Division, Seattle, WA | Seattle | Washington | 98108-1532 | Jose M. Garcia, MD PhD (STUDY_CHAIR) |
Find similar trials in Birmingham, AL
By research site
Birmingham VA Medical Center, Birmingham, AL· Birmingham, ALPhoenix VA Health Care System, Phoenix, AZ· Phoenix, AZVA Palo Alto Health Care System, Palo Alto, CA· Palo Alto, CAVA San Diego Healthcare System, San Diego, CA· San Diego, CARocky Mountain Regional VA Medical Center, Aurora, CO· Aurora, COWashington DC VA Medical Center, Washington, DC· Washington D.C., DC
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