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

Status: Recruiting
Location: See location...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 40
Healthy Volunteers: t
View:

• 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

Locations
United States
Pennsylvania
Neuromuscular Research Laboratory
RECRUITING
Pittsburgh
Contact Information
Primary
Bradley C Nindl, PhD
bnindl@pitt.edu
412-246-0460
Backup
Kristin J Koltun, PhD
kjk116@pitt.edu
412-246-0460
Time Frame
Start Date: 2024-07-15
Estimated Completion Date: 2026-08-01
Participants
Target number of participants: 120
Treatments
No_intervention: CONTROL (men + women)
The control group will maintain their habitual exercise, diet, and sleep patterns, all of which will be monitored throughout the study.
Active_comparator: STRESS (men + women): Multi-Stressor Training
Research volunteers will be randomized into the stress exposure group (STRESS) will undergo a 4-week exercise training program consisting of 5 consecutive days of strenuous physical training followed by 2 days of recovery (energy balance, no structured exercise). The exercise training program will consist of military-relevant physical training exercises (e.g., load carriage, aerobic and resistance exercises) that progressively increase in duration and intensity to increase exercise energy expenditure. Participants will perform multiple exercises per day using a variety of endurance and muscle loading modalities designed to mimic movements typically observed during real-life military operations.
Experimental: SUPPRESS (men): Multi-Stressor Training + Zoladex + AndroGel 1.25g
In addition to participating in the multi-stressor training program, male participants randomized to the GnRH suppressed (SUPPRESS) group will be administered a long-acting GnRH agonist (Zoladex) by trained medical professionals to suppress endogenous gonadal steroids. Following GnRH agonist administration, men will be administered 1.25g/day (SUPPRESS) of topical 1% testosterone gel (AndroGel, Abbvie, North Chicago, IL) to be applied to the shoulders, upper arms, and/or stomach area daily.
Experimental: SUPPRESS (women): Multi-stressor training + Zoladex + Placebo patch
In addition to participating in the multi-stressor training program, male participants randomized to the GnRH suppressed (SUPPRESS) group will be administered a long-acting GnRH agonist (Zoladex) by trained medical professionals to suppress endogenous gonadal steroids. Following GnRH agonist administration, women in the SUPRESS group will receive a placebo transdermal patch.
Experimental: REPLACE (men): Multi-Stressor Training + Zoladex + AndroGel 5g
Following GnRH agonist administration, men will be administered 5g/day (REPLACE) of topical 1% testosterone gel (AndroGel, Abbvie, North Chicago, IL) to be applied to the shoulders, upper arms, and/or stomach area daily.
Experimental: REPLACE (women): Multi-Stressor Training + Zoladex + Climara Pro Patch
Following GnRH agonist administration, women, the REPLACE group will receive a transdermal estradiol (0.045 mg/day) + levonorgestrel (0.015 mg/day) patch (Climara Pro, Bayer, NJ) to be placed on a clean, dry area of the skin on the lower
Related Therapeutic Areas
Sponsors
Collaborators: U.S. Army Medical Research and Development Command
Leads: Bradley Nindl

This content was sourced from clinicaltrials.gov