About this trial
Non-combat-related muscle, tendon and bone injuries are the most common injuries suffered by military personnel, particularly in new recruits. These injuries impact military readiness and are responsible for roughly 60% of limited duty days, 65% of soldiers who are unable to deploy, and nearly $500 million in medical cost to the government annually in the Army alone. Drug interventions must be studied and developed to prevent these negative outcomes and prepare military personnel for the demands of military service. At the current time, military leadership has identified critical gaps in understanding how to minimize these injuries and train soldiers with drug intervention serving among those gaps.
The goal of this study is to determine how a hormonal intervention can change muscle, tendon, and bone function as well as physical and psychological performance in response to mental and physical stress. To do so, we will examine sex hormone (testosterone, estrogen) levels, muscle, tendon, and bone images, blood samples, and physical and mental performance. We will look at things like changes in hormone levels, chemicals released from active skeletal muscles, and your body composition. The results from this study will be used to improve physical readiness training in the military with the goal of reducing injuries.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age 18-40 years
body mass index (BMI) 18-30 kg/m2
weight stable (±10 lbs) in past 2 months
takes part in moderate physical activity for at least 150 minutes/week
Disqualifiers
None
Trial design
Parallel
Treatments tested in this trial
Goserelin 3.6 MG
DrugGoserelin acetate (Zoladex) is a gonadotropin-releasing hormone agonist (GnRH). GnRH agonists induce a transient increase in sex hormone concentrations, but subsequently inhibit gonadotropin secretion and the production of testosterone in men and estrogen in women. An equilibration period will occur to allow steroid concentrations to reduce.
Multi-Stressor Training
Other interventionA 4-week physical training program that mimics military training.
Testosterone gel (AndroGel 5g)
DrugMale subjects will be randomly assigned to receive a topical testosterone gel (5g dose).
Testosterone gel (AndroGel 1.25g)
DrugMale subjects will be randomly assigned to receive a topical testosterone gel (1.25g dose).
Treatment groups
Trial outcomes
Primary outcomes
Biomechanical: Tendon Cross-Sectional Area, change from baseline and throughout training, mean
Biomechanical: Tendon Shear Wave Elastography, change from baseline and throughout training, mean
Biomechanical: Tendon Thickness, change from baseline and throughout training, mean
Biomechanical: Quadriceps Muscle Cross-sectional Area, change from baseline and throughout training, mean
Secondary outcomes
Bone microarchitecture: High Resolution- peripheral Computed Tomography, change from baseline, mean
Biochemical: Cell culture, extracellular vesicles, micro- RNAs, change from baseline and throughout study, mean
Biochemical: Measures of inflammation (IL6, IL-1B, TNFa, CRP), change from baseline and throughout study, mean
Biochemical: Measures of anabolism (Growth Hormone, Insulin-like growth factor-1), change from baseline and throughout study, mean
Sponsors and contacts
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Bradley Nindl
Lead sponsor
University of Pittsburgh
Sponsor institution
U.S. Army Medical Research and Development Command
Collaborator