Adaptions and Resiliency to Multi-Stressor OpeRations

Description

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.

Conditions

Musculoskeletal Injury, Hypogonadism

Study Overview

Study Details

Study overview

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.

Musculoskeletal Resiliency and Adaptation to Sex Steroid Suppression and Replacement During Multi-Stressor Training

Adaptions and Resiliency to Multi-Stressor OpeRations

Condition
Musculoskeletal Injury
Intervention / Treatment

-

Contacts and Locations

Pittsburgh

Neuromuscular Research Laboratory, Pittsburgh, Pennsylvania, United States, 15203

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Age 18-40 years
  • 2. body mass index (BMI) 18-30 kg/m2
  • 3. weight stable (±10 lbs) in past 2 months
  • 4. takes part in moderate physical activity for at least 150 minutes/week
  • 5. currently free of upper or lower body /extremity injury or impairment
  • 6. able to commit to study duration
  • 7. agrees to adhere to study requirements
  • 8. not taking prescription medications or be willing to refrain from medication prior to and throughout the study period, unless approved by study physician
  • 9. in men, total testosterone concentration within normal physiological range (300-1000 ng/dL)
  • 10. in women, eumenorrheic (cycles of 26-35 days) and not using hormonal contraceptives for previous 3 months
  • 1. Current smoker
  • 2. current clinical diagnosis of an eating disorder
  • 3. use of medication incompatible with measurement of reproductive and metabolic hormones or which may interfere with any of the study outcomes
  • 4. current oligo/amenorrhea in women
  • 5. any metabolic or endocrine disease
  • 6. has been diagnosed with a medical condition, physical or psychological, that currently prevents potential subjects from exercising
  • 7. currently pregnant or becomes pregnant during the study
  • 8. history of heart condition OR high blood pressure
  • 9. treating physician requires subject participates in medically supervised physical activity only
  • 10. history of drug addiction, or regular use of recreational drugs
  • 11. currently undergoing treatment for or have a history of mental health conditions
  • 12. irregular lab results (e.g., PSA \>3 ng/mL)
  • 13. Current diagnoses of disorders known to affect bone metabolism including hyperthyroidism, hyperparathyroidism, osteomalacia, Cushing's, diabetes mellitus or renal insufficiency
  • 14. 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.
  • 15. History of deep vein thrombosis, pulmonary embolism, or clotting disorders.
  • 16. History of stroke or myocardial infarction
  • 17. Serum 25-hydroxyvitamin D \< 20 ng/mL
  • 18. Thyroid dysfunction
  • 19. Serum creatinine \> 2 mg/dL
  • 20. Personal history or history of a first-degree relative with breast cancer
  • 21. Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \> 2x the upper limit of normal
  • 22. Serum bilirubin \> 2 mg/dL
  • 23. Serum alkaline phosphatase \> 150 U/L
  • 24. Plasma hemoglobin \< 10 gm/dL
  • 25. Hematocrit \> 50
  • 26. Fracture within the last 6 months.
  • 27. Serum testosterone level \< 270 or \> 1070 ng/dL
  • 28. Systolic blood pressure \> 160 or diastolic blood pressure \> 95
  • 29. Active substance abuse
  • 30. Triglycerides \> 150 fasting
  • 31. History of hereditary angioedema
  • 32. History of chest pain at rest, during daily activities of living, or when performing physical activity
  • 33. Musculoskeletal injury removing subject from physical activity for more than a month within the past 2 years
  • 34. Recreational drug use more than 2 times per month in each of the previous 6 months
  • 35. Self-reported vision is worse than 20/20.
  • 36. Personal history or history of a first-degree relative with breast cancer
  • 37. Experienced a fracture within the last 6 months
  • 38. participated and taken investigational drug in any other clinical trial (including bioequivalence study) within six months prior to study drug administration
  • 39. Diagnosed with eating disorder
  • 40. Have food allergies, intolerance, restriction, or special diet needs
  • 41. History of endometriosis
  • 42. Current diagnosis of reproductive health issues, such as ovarian cysts, PCOS, pelvic lesions, undiagnosed ovarian enlargement
  • 43. Have undiagnosed abnormal vaginal bleeding
  • 44. Currently breastfeeding or within 2 months after stopping breastfeeding
  • 45. Have dietary restrictions

Ages Eligible for Study

18 Years to 40 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Bradley Nindl,

Bradley C Nindl, PhD, PRINCIPAL_INVESTIGATOR, University of Pittsburgh

Study Record Dates

2026-08-01