Adaptions and Resiliency to Multi-Stressor OpeRations

Recruiting now · Phase 4 · Has a placebo group

Conditions studied: Musculoskeletal Injury, Hypogonadism

In brief

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.

Key facts

Study ID

NCT06455969

Run by

Bradley Nindl

People needed

120

Starts

2024-07-15

Expected to finish

2026-08-01

Last updated by the study team

2025-08-24

Who can join

Age: 18 and older, up to 40. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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
• currently free of upper or lower body /extremity injury or impairment
• able to commit to study duration
• agrees to adhere to study requirements
• not taking prescription medications or be willing to refrain from medication prior to and throughout the study period, unless approved by study physician
• in men, total testosterone concentration within normal physiological range (300-1000 ng/dL)
• in women, eumenorrheic (cycles of 26-35 days) and not using hormonal contraceptives for previous 3 months

You may not qualify if…

• Current smoker
• current clinical diagnosis of an eating disorder
• use of medication incompatible with measurement of reproductive and metabolic hormones or which may interfere with any of the study outcomes
• current oligo/amenorrhea in women
• any metabolic or endocrine disease
• has been diagnosed with a medical condition, physical or psychological, that currently prevents potential subjects from exercising
• currently pregnant or becomes pregnant during the study
• history of heart condition OR high blood pressure
• treating physician requires subject participates in medically supervised physical activity only
• history of drug addiction, or regular use of recreational drugs
• currently undergoing treatment for or have a history of mental health conditions
• irregular lab results (e.g., PSA >3 ng/mL)
• Current diagnoses of disorders known to affect bone metabolism including hyperthyroidism, hyperparathyroidism, osteomalacia, Cushing's, diabetes mellitus or renal insufficiency
• Current use of medications known to affect bone metabolism including estrogens, androgens, anti-estrogens, bisphosphonates (oral bisphosphonates within one year of the baseline visit or IV bisphosphonates within three years of the baseline visit), calcitonin, fluoride, oral or inhaled glucocorticoids, suppressive doses of thyroxine, lithium, pharmacological doses of vitamin D (greater than 2000 IU/day), anti-convulsants, depot medroxyprogesterone within 6 months.
• History of deep vein thrombosis, pulmonary embolism, or clotting disorders.
• History of stroke or myocardial infarction
• Serum 25-hydroxyvitamin D < 20 ng/mL
• Thyroid dysfunction
• Serum creatinine > 2 mg/dL
• Personal history or history of a first-degree relative with breast cancer
• Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) > 2x the upper limit of normal
• Serum bilirubin > 2 mg/dL
• Serum alkaline phosphatase > 150 U/L
• Plasma hemoglobin < 10 gm/dL
• Hematocrit > 50

Where it is running

• Neuromuscular Research Laboratory — Pittsburgh, Pennsylvania, United States (enrolling)

Full record on ClinicalTrials.gov

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