Growth Hormone Replacement Therapy for Veterans with Mild Traumatic Brain Injury and Adult Growth Hormone Deficiency A Phase 3 Randomized, Placebo-Controlled Study

What this Trial Is About

Researchers are evaluating the effects of growth hormone replacement therapy GHRT compared to a placebo in veterans with adult growth hormone deficiency AGHD and mild traumatic brain injury mTBI. The study aims to assess whether GHRT helps improve quality of life in these patients. This is a Phase 3 randomized, quadruple-blinded treatment study sponsored by the VA Office of Research and Development. Participants will be randomly assigned in equal groups to receive either recombinant human growth hormone Somatropin or a placebo for six months. Follow-up visits occur in-clinic on Days 14, 40, 65, 90 3 months, and 180 6 months. After six months of treatment, patients stop the study medication and have an additional safety follow-up two weeks later to ensure wellness and support transition back to regular care. During the study, participants will undergo assessments including quality of life measured by the QoL-AGHDA scale at 6 months, and body composition evaluation. The study involves regular monitoring visits to track treatment effects and safety. Total participation includes the six months of treatment plus a two-week safety follow-up, during which researchers will review patient well-being and quality of life improvements.

Growth Hormone Replacement Therapy in Veterans With Mild Traumatic Brain Injury (mTBI) and Adult Growth Hormone Deficiency (AGHD)