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治験 NCT06455969 (ARMOR)（対象：筋骨格損傷、性腺機能低下症）は募集中です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。
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Adaptions and Resiliency to Multi-Stressor OpeRations (ARMOR)

募集中
治験(臨床試験)の詳細は主に英語で提供されています。しかし、治験レーダーAIが支援できます！「治験を説明」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT06455969 (ARMOR) は 筋骨格損傷、性腺機能低下症 に関する 基礎研究 の研究で、第IV相・第四段階 介入研究 臨床試験 です。現在は 募集中 で、2024年7月15日 から開始しています。120 名の参加者 の募集が計画されています。この治験は Bradley Nindl によって主催され、2026年8月1日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2025年8月24日 です。
概要
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.

詳細説明
Suppression of the reproductive hypothalamic-pituitary-gonadal (HPG) axis is a common physiological response to strenuous military training and can be difficult to replicate in simulated environments. Additionally, whether HPG suppression contributes to the physiological changes, performance decrements, and high MSK injury risk associated with multi-stressor military training is unknown. Thus, we will utilize pharmacological inhibition of the HPG axis to test if estrogen and testosterone replacement will mitigate injury risk and performance decrements following military-relevant multi-stressor training. This project aims to deliver a state-of-the-art evaluation of male and female adaptive responses to multi-stressor training and evidence-based guidance for the safe and ethical use of exogenous hormone replacement as a MSK injury mitigation solution during multi-stressor training and operations.
公式タイトル

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

疾患／病気
筋骨格損傷性腺機能低下症
その他の研究識別子
  • ARMOR
  • STUDY23090134
NCT番号
NCT06455969
開始日
2024-07-15
最終更新日
2025-08-24
終了予定日
2026-08-01
目標参加者数
120
試験の種類
介入研究
治験の相・段階
第IV相・第四段階
状況
募集中
キーワード
Military
Multi-stressor Training
Tendon
Muscle
Bone
主目的
基礎研究
割付方法
無作為化
介入モデル
並行割当
盲検化
単盲検
群（アーム）／介入
参加グループ/群介入/治療法
非介入CONTROL (men + women)
The control group will maintain their habitual exercise, diet, and sleep patterns, all of which will be monitored throughout the study.
該当なし
実薬対照薬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.
Multi-stressor Training
A 4-week physical training program that mimics military training.
実験的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.
Goserelin 3.6 MG
Goserelin 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
A 4-week physical training program that mimics military training.
Testosterone Gel (Androgel 1.25g)
Male subjects will be randomly assigned to receive a topical testosterone gel (1.25g dose).
実験的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.
Goserelin 3.6 MG
Goserelin 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
A 4-week physical training program that mimics military training.
プラセボパッチ
Female subjects will be randomly assigned to receive a placebo patch identical to the Climara Pro patch.
実験的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.
Goserelin 3.6 MG
Goserelin 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
A 4-week physical training program that mimics military training.
Testosterone Gel (Androgel 5g)
Male subjects will be randomly assigned to receive a topical testosterone gel (5g dose).
実験的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
Goserelin 3.6 MG
Goserelin 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
A 4-week physical training program that mimics military training.
Estradiol / Levonorgestrel Transdermal System [Climara Pro]
Female subjects will be randomly assigned to receive a estrogen/ progesterone patch.
主要評価項目
評価指標指標の説明時間枠
Biomechanical: Tendon Cross-Sectional Area, change from baseline and throughout training, mean
Through study completion, an average of 8 weeks
Biomechanical: Tendon Shear Wave Elastography, change from baseline and throughout training, mean
Through study completion, an average of 8 weeks
Biomechanical: Tendon Thickness, change from baseline and throughout training, mean
Through study completion, an average of 8 weeks
Biomechanical: Quadriceps Muscle Cross-sectional Area, change from baseline and throughout training, mean
Through study completion, an average of 8 weeks
Biomechanical: Quadriceps Muscle Echointensity, change from baseline and throughout training, mean
Through study completion, an average of 8 weeks
Body composition: Lean mass, change from baseline, mean
Through study completion, an average of 8 weeks
Body Composition: Fat mass, change from baseline, mean
Through study completion, an average of 8 weeks
Body Composition: Body mass, change from baseline and throughout training, mean
Through study completion, an average of 8 weeks
Body Composition: Body Fat Percentage, change from baseline, mean
Through study completion, an average of 8 weeks
Biochemical: Bone turnover markers (CTx + P1NP), change from baseline, mean
Through study completion, an average of 8 weeks
Biochemical: Sex steroid hormones (Testosterone, Sex Hormone Binding Globulin, Estradiol), change from baseline and throughout training, mean
Through study completion, an average of 8 weeks
副次評価項目
評価指標指標の説明時間枠
Bone microarchitecture: High Resolution- peripheral Computed Tomography, change from baseline, mean
Through study completion, an average of 8 weeks
Biochemical: Cell culture, extracellular vesicles, micro- RNAs, change from baseline and throughout study, mean
Through study completion, an average of 8 weeks
Biochemical: Measures of inflammation (IL6, IL-1B, TNFa, CRP), change from baseline and throughout study, mean
Through study completion, an average of 8 weeks
Biochemical: Measures of anabolism (Growth Hormone, Insulin-like growth factor-1), change from baseline and throughout study, mean
Through study completion, an average of 8 weeks
適格基準

対象年齢
成人
試験の最低年齢
18 Years
対象性別
全て
健康なボランティアを受け入れる
はい
  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
Bradley Nindl logoBradley Nindl
U.S. Army Medical Research and Development Command logoU.S. Army Medical Research and Development Command
責任者
Bradley Nindl, 治験依頼者・主任研究者, Professor, University of Pittsburgh
試験中央連絡先
連絡先: Bradley C Nindl, PhD, 412-246-0460, [email protected]
連絡先: Kristin J Koltun, PhD, 412-246-0460, [email protected]
1 1カ国の場所

Pennsylvania

Neuromuscular Research Laboratory, Pittsburgh, Pennsylvania, 15203, United States
Brian J Martin, PhD, 連絡先, 412-246-0460, [email protected]
募集中