<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04460872</url>
  </required_header>
  <id_info>
    <org_study_id>649726</org_study_id>
    <nct_id>NCT04460872</nct_id>
  </id_info>
  <brief_title>Locomotor Training With Testosterone to Promote Bone and Muscle Health After Spinal Cord Injury</brief_title>
  <official_title>Locomotor Training With Testosterone to Promote Bone and Muscle Health</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>North Florida Foundation for Research and Education</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>North Florida/South Georgia Veterans Health System</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Brooks Rehabilitation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Florida</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>North Florida Foundation for Research and Education</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This pilot study will determine the feasibility of implementing a combinatory rehabilitation&#xD;
      strategy involving testosterone replacement therapy (TRT) with locomotor training (LT;&#xD;
      walking on a treadmill with assistance and overground walking) in men with testosterone&#xD;
      deficiency and walking dysfunction after incomplete or complete spinal cord injury. The&#xD;
      investigators hypothesize that LT+TRT treatment will improve muscle size and bone mineral&#xD;
      density in men with low T and ambulatory dysfunction after incomplete or complete SCI, along&#xD;
      with muscle fundtion and walking recovery in men with T low and ambulatory dysfunction ater&#xD;
      incomplete SCI.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Spinal cord injury (SCI) produces bone, muscle, and neural impairments that increase fracture&#xD;
      risk and impede recovery of physical function. Locomotor training (LT) increases muscle size&#xD;
      and promotes recovery of muscle function and walking in some persons with incomplete SCI. It&#xD;
      is unknown if testosterone replacement therapy (TRT) improves these factors in men who have&#xD;
      walking dysfunction and low testosterone after incomplete SCI. In addition, the combined&#xD;
      effects of LT plus TRT remain unknown in men with incomplete SCI.&#xD;
&#xD;
      For this pilot study, men with chronic incomplete SCI involving spinal level L1 or above or&#xD;
      complete SCI involving spinal levels T2-L1, with upper motor neuron signs, who have low&#xD;
      testosterone and walking dysfunction will receive 6-months of TRT alone or TRT with LT. TRT&#xD;
      injections will be given weekly. LT will involve 35 sessions of treadmill walking with&#xD;
      assistance and overground walking (4 sessions per week) during the initial 2-3 months of TRT.&#xD;
      Participants will be assessed at study entry and at 1-6 month intervals thereafter. Testing&#xD;
      will include measurements such as a magnetic resonance imaging (MRI) scans, dual energy x-ray&#xD;
      absorptiometry (DEXA) scan, and muscle performance and walking tests. Participants will also&#xD;
      undergo safety tests, including physical exams, electrocardiogram (ECG), prostate digital&#xD;
      rectal exam, and blood tests to assess hematocrit, liver enzymes (AST and ALT), prostate&#xD;
      specific antigen (PSA), and other health markers. The treatment groups will be compared with&#xD;
      a non-treatment control group comprised of men with incomplete or complete SCI who receive no&#xD;
      treatment. Participants enrolled in the non-treatment control group will undergo the same&#xD;
      tests described above.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 31, 2021</start_date>
  <completion_date type="Anticipated">January 30, 2024</completion_date>
  <primary_completion_date type="Anticipated">January 30, 2024</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>change in thigh muscle cross-sectional area</measure>
    <time_frame>baseline, 3 months, 6 months</time_frame>
    <description>change in thigh muscle cross-sectional area assessed via MRI</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change in 6 min walk test (6MWT)</measure>
    <time_frame>baseline, 1 month, 3 months, 6 months</time_frame>
    <description>change in distance covered on 6MWT</description>
  </primary_outcome>
  <primary_outcome>
    <measure>change in distal femur bone mineral density</measure>
    <time_frame>baseline, 3 months, 6 months</time_frame>
    <description>change in distal femur bone mineral density (BMD) assessed via DEXA</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>change in knee extensor peak torque</measure>
    <time_frame>baseline, 3 months, 6 months</time_frame>
    <description>change in knee extensor peak torque assessed via dynamometry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in 10m walk test (10mWT)</measure>
    <time_frame>baseline, 1 month, 3 months, 6 months</time_frame>
    <description>change in time to complete 10mWT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in bone resorption marker</measure>
    <time_frame>baseline, 3 months, 6 months</time_frame>
    <description>change in circulating bone resorption marker</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change in bone formation marker</measure>
    <time_frame>baseline, 3 months, 6 months</time_frame>
    <description>change in circulating bone formation marker</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">21</enrollment>
  <condition>Spinal Cord Injury</condition>
  <condition>Spinal Cord Injuries</condition>
  <condition>Trauma, Nervous System</condition>
  <condition>Wounds and Injury</condition>
  <condition>Central Nervous System Diseases</condition>
  <condition>Spinal Cord Diseases</condition>
  <condition>Gonadal Disorders</condition>
  <condition>Endocrine System Diseases</condition>
  <condition>Hypogonadism</condition>
  <condition>Genital Diseases, Male</condition>
  <condition>Spinal Cord Trauma</condition>
  <condition>Injuries, Spinal Cord</condition>
  <condition>Walking, Difficulty</condition>
  <condition>Gait Disorders, Neurologic</condition>
  <condition>Locomotion Disorder, Neurologic</condition>
  <condition>Wounds and Injuries</condition>
  <condition>Nervous System Diseases</condition>
  <condition>Testosterone Deficiency</condition>
  <condition>Androgen Deficiency</condition>
  <condition>Hormone Deficiency</condition>
  <arm_group>
    <arm_group_label>testosterone enanthate</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Testosterone enanthate via i.m. injection (100 mg/week)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>locomotor training, testosterone enanthate</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Treadmill and overground walking training and testosterone enanthate via i.m. injection (100 mg/week)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>non-interventional control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Non-interventional control group</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Testosterone Enanthate</intervention_name>
    <description>Subjects receive testosterone (100 mg/week) by intramuscular injection</description>
    <arm_group_label>locomotor training, testosterone enanthate</arm_group_label>
    <arm_group_label>testosterone enanthate</arm_group_label>
    <other_name>delatestryl</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Locomotor Training</intervention_name>
    <description>Subjects receive locomotor training (4 sessions/week for 2-3 months)</description>
    <arm_group_label>locomotor training, testosterone enanthate</arm_group_label>
    <other_name>Treadmill training and overground walking</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men &gt;18 years of age&#xD;
&#xD;
          -  Diagnosis of an incomplete SCI involving spinal segments L1 or above or a clinically&#xD;
             complete SCI involving spinal segments T2-L1, with upper motor neuron injury signs&#xD;
             (i.e., spasticity, hypertonicity) for &gt;60-days&#xD;
&#xD;
          -  Low serum total testosterone (&lt;300 ng/dL), bioavailable testosterone (&lt;110 ng/dL), or&#xD;
             free testosterone (&lt;46 pg/mL or &lt;4.6 ng/dL)&#xD;
&#xD;
          -  Presence of one or more sign or symptom that may be related to low testosterone,&#xD;
             including: loss of body hair or reduced shaving, very small testes (&lt;6 mL), reduced&#xD;
             sexual desire (libido) and activity, decreased spontaneous erections (e.g., morning&#xD;
             erections) or erectile dysfunction, breast discomfort or gynecomastia, height loss,&#xD;
             low-trauma fracture, or low BMD, hot flushes or sweats, decreased energy, motivation,&#xD;
             initiative, or self-confidence, fatigue or irritability, feeling sad or blue, having a&#xD;
             depressed mood, or having a persistent low-grade depressive disorder, poor&#xD;
             concentration or memory, sleep disturbances or increased sleepiness, mild unexplained&#xD;
             anemia (normochromic or normocytic), reduced muscle bulk, strength, or physical&#xD;
             performance, Increased body fat or body mass index, any other sign or symptom commonly&#xD;
             associated with low testosterone&#xD;
&#xD;
          -  Locomotor dysfunction, definted as self-selected walking pace ≤1.0 m/s on a 10mWT,&#xD;
             either with or without gait devices or braces and with or without assistance, or as&#xD;
             self-selected walking pace &gt;1.0 m/s with reliance on a gait device or brace or with&#xD;
             highly compensated movement impairments, as identified by a trained observer.&#xD;
&#xD;
          -  Diagnosis of first time SCI including etiology from trauma, vascular, or orthopedic&#xD;
             pathology&#xD;
&#xD;
          -  Medically-stable condition that is asymptomatic for conditions that will interfere&#xD;
             with the study participation&#xD;
&#xD;
          -  Willingness to administer TRT as instructed by the study staff and to abide by study&#xD;
             protocol&#xD;
&#xD;
          -  Documented approval from the study physician verifying medical status&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Currently participating in another research protocol that may influence study&#xD;
             outcomes.&#xD;
&#xD;
          -  Mental state that precludes understanding the study protocol.&#xD;
&#xD;
          -  Life expectancy &lt;12-months.&#xD;
&#xD;
          -  History of or current congenital SCI (e.g., Chiari malformation, myelomeningocele,&#xD;
             intraspinal neoplasm, Frederich's ataxis) or other degenerative spinal disorder (e.g.,&#xD;
             spinocerebellar degeneration) that may complicate study procedures&#xD;
&#xD;
          -  Multiple sclerosis, amyotrophic lateral sclerosis, or other neurologic impairment or&#xD;
             injury&#xD;
&#xD;
          -  Current prostate, breast, or other organ cancer or a history of prostate or breast&#xD;
             cancer&#xD;
&#xD;
          -  Any other diagnosed or treated cancer within the past 24-months, with the exceptions&#xD;
             of basal or squamous cell carcinoma of the skin that has been successfully treated&#xD;
&#xD;
          -  Serum prostate-specific antigen (PSA) &gt;3.0 ng/mL [men treated with 5-alpha reductase&#xD;
             inhibitors (e.g., finasteride or dutasteride) are eligible to participate if PSA&#xD;
             values are ≤1.5 ng/mL]&#xD;
&#xD;
          -  Prostate nodule or induration noted on digital rectal exam (DRE) during screening that&#xD;
             tests positive for prostate cancer&#xD;
&#xD;
          -  Currently seeking fertility or expected during the duration of the study&#xD;
&#xD;
          -  Gynecomastia&#xD;
&#xD;
          -  Hematocrit (HCT) &gt;49%&#xD;
&#xD;
          -  Any major cardiovascular (CV) event within the last 12-months (defined as a history of&#xD;
             acute myocardial infarction, any cardiac revascularization procedure including&#xD;
             angioplasty, stenting, or coronary artery bypass grafting, revascularization of the&#xD;
             carotid or middle cerebral artery or procedures to treat critical limb ischemia, or&#xD;
             hospitalization due to unstable angina, transient ischemic attack, stroke, or&#xD;
             peripheral vascular disease)&#xD;
&#xD;
          -  Angina that is not controlled on a current medical regimen (Canadian class II, III, or&#xD;
             IV)&#xD;
&#xD;
          -  Poorly compensated congestive heart failure (NYHA class III or IV)&#xD;
&#xD;
          -  Poorly controlled hypertension (consistently measured systolic BP ≥160 mmHg or&#xD;
             diastolic BP ≥100 mmHg), while on medications&#xD;
&#xD;
          -  Poorly controlled arrhythmia of any type&#xD;
&#xD;
          -  Severe valvular heart disease&#xD;
&#xD;
          -  Baseline electrocardiogram (ECG) findings such as left bundle branch block or marked&#xD;
             ECG abnormalities that would preclude serial screening evaluations for occult ischemic&#xD;
             events&#xD;
&#xD;
          -  History of unprovoked deep venous thrombosis (DVT), unprovoked pulmonary embolism,&#xD;
             history of recurrent DVT or known thrombophilia&#xD;
&#xD;
          -  LDL cholesterol &gt;160 mg/dL with history of any major CV event, defined above, within&#xD;
             the last 12-months&#xD;
&#xD;
          -  Major non-CV surgery (e.g., major abdominal or thoracic procedure) within 90-days&#xD;
             prior to screening and/or a major surgery scheduled at the time of screening&#xD;
&#xD;
          -  Liver enzymes (AST or ALT) &gt;1.5 times the normal upper limit&#xD;
&#xD;
          -  Severe or end-stage chronic kidney disease documented by estimated glomerular&#xD;
             filtration rate (eGFR) &lt;30 mL/min&#xD;
&#xD;
          -  Diagnosed, but untreated severe obstructive sleep apnea&#xD;
&#xD;
          -  Lower extremity fracture in the last 12-months (exclusion criterion for participation&#xD;
             in LT+TRT group only)&#xD;
&#xD;
          -  Femoral neck, total hip, or lumbar spine t-score below -2.5 or distal femur BMD &lt;0.70&#xD;
             g/cm2, assessed via DEXA at screening (exclusion criterion for participation in LT+TRT&#xD;
             group only)&#xD;
&#xD;
          -  Current anticoagulant therapy (contraindication for i.m. injections)&#xD;
&#xD;
          -  Use of any of the following pharmacologic agents in the previous 90-days: any TRT&#xD;
             formulation, any compounded or over-the-counter androgenic hormones or androgen&#xD;
             precursors, clomiphene, aromatase inhibitors, anti-estrogen or estrogen treatment, or&#xD;
             growth hormone&#xD;
&#xD;
          -  Use of anti-resorptive or bone anabolic drug therapy in the previous 180-days&#xD;
&#xD;
          -  Acute use (&gt;5-days) of any opioids (e.g., oxycodone, hydrocodone, etc) or systemic&#xD;
             glucocorticoids &gt;7.5 mg/d prednisone equivalent (e.g., hydrocortisone 30 mg,&#xD;
             methylprednisolone 6 mg, or dexamethasone 1.2 mg) within 1-week before screening&#xD;
             visit, except men who are taking these medications for a chronic condition and are&#xD;
             anticipated to continue treatment for the study duration&#xD;
&#xD;
          -  Known allergy to any component of the TRT formulation (e.g., sesame oil or cottonseed&#xD;
             oil)&#xD;
&#xD;
          -  Any other condition, therapy, lab abnormality, medical or psychiatric conditions, or&#xD;
             reason that might pose a risk to the participant, make participation not in the&#xD;
             person's best interest, confound the study results (e.g., inability to comply with&#xD;
             study requirements), make the participant unsuitable to receive study intervention, or&#xD;
             interfere with the person's ability to participate for the entire study duration&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Participants must be male</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Joshua F Yarrow, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>North Florida/South Georgia Veterans Health System</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Joshua F Yarrow, PhD</last_name>
    <phone>(352) 548-6477</phone>
    <email>joshua.yarrow@va.gov</email>
  </overall_contact>
  <location>
    <facility>
      <name>North Florida/South Georgia Veterans Health System</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32608</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Joshua F Yarrow, PhD</last_name>
      <phone>352-548-6477</phone>
      <email>joshua.yarrow@va.gov</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Brooks Rehabilitation</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32216</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Emily J Fox, DPT, PhD</last_name>
      <phone>352-273-6117</phone>
      <email>ejfox@phhp.ufl.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>July 6, 2020</study_first_submitted>
  <study_first_submitted_qc>July 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 8, 2020</study_first_posted>
  <last_update_submitted>April 5, 2023</last_update_submitted>
  <last_update_submitted_qc>April 5, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 7, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>North Florida Foundation for Research and Education</investigator_affiliation>
    <investigator_full_name>Joshua Yarrow</investigator_full_name>
    <investigator_title>Research Health Scientist</investigator_title>
  </responsible_party>
  <keyword>Testosterone</keyword>
  <keyword>Testosterone enanthate</keyword>
  <keyword>Testosterone undecanoate</keyword>
  <keyword>Testosterone 17 beta-cypionate</keyword>
  <keyword>Methyltestosterone</keyword>
  <keyword>Androgens</keyword>
  <keyword>Hormones</keyword>
  <keyword>Hormone Substitutes, and Hormone Antagonists</keyword>
  <keyword>Physiologic Effects of Drugs</keyword>
  <keyword>Pharmacologic Actions</keyword>
  <keyword>Therapeutic Uses</keyword>
  <keyword>Anabolic Agents</keyword>
  <keyword>Testosterone Replacement Therapy</keyword>
  <keyword>Dual Energy X ray Absorptiometry</keyword>
  <keyword>Lean Tissue Mass</keyword>
  <keyword>Body Composition</keyword>
  <keyword>Muscle Strength</keyword>
  <keyword>Muscle Mass</keyword>
  <keyword>Bone Mineral Density</keyword>
  <keyword>Adipose Tissue</keyword>
  <keyword>Body Fat</keyword>
  <keyword>Density, Bone</keyword>
  <keyword>Bone Formation</keyword>
  <keyword>Bone Resorption</keyword>
  <keyword>Bone Density Conservation Agents</keyword>
  <keyword>Magnetic Resonance Imaging</keyword>
  <keyword>Walking</keyword>
  <keyword>Ambulation</keyword>
  <keyword>Locomotor</keyword>
  <keyword>Locomotion</keyword>
  <keyword>Treadmill</keyword>
  <keyword>Spinal Cord Injury</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spinal Cord Injuries</mesh_term>
    <mesh_term>Nervous System Diseases</mesh_term>
    <mesh_term>Central Nervous System Diseases</mesh_term>
    <mesh_term>Gait Disorders, Neurologic</mesh_term>
    <mesh_term>Spinal Cord Diseases</mesh_term>
    <mesh_term>Trauma, Nervous System</mesh_term>
    <mesh_term>Genital Diseases</mesh_term>
    <mesh_term>Genital Diseases, Male</mesh_term>
    <mesh_term>Hypogonadism</mesh_term>
    <mesh_term>Endocrine System Diseases</mesh_term>
    <mesh_term>Gonadal Disorders</mesh_term>
    <mesh_term>Mobility Limitation</mesh_term>
    <mesh_term>Wounds and Injuries</mesh_term>
    <mesh_term>Spinal Injuries</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Methyltestosterone</mesh_term>
    <mesh_term>Testosterone</mesh_term>
    <mesh_term>Testosterone undecanoate</mesh_term>
    <mesh_term>Testosterone enanthate</mesh_term>
    <mesh_term>Testosterone 17 beta-cypionate</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Data will be shared according to the requirements described by the Department of Veterans Affairs, Office of Research &amp; Development.</ipd_description>
    <ipd_time_frame>Data will be shared according to the requirements described by the Department of Veterans Affairs, Office of Research &amp; Development.</ipd_time_frame>
    <ipd_access_criteria>Data will be shared according to the requirements described by the Department of Veterans Affairs, Office of Research &amp; Development.</ipd_access_criteria>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04460872
org study id: 649726
nct id: NCT04460872
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
This pilot study will determine the feasibility of implementing a combinatory rehabilitation
      strategy involving testosterone replacement therapy (TRT) with locomotor training (LT;
      walking on a treadmill with assistance and overground walking) in men with testosterone
      deficiency and walking dysfunction after incomplete or complete spinal cord injury. The
      investigators hypothesize that LT+TRT treatment will improve muscle size and bone mineral
      density in men with low T and ambulatory dysfunction after incomplete or complete SCI, along
      with muscle fundtion and walking recovery in men with T low and ambulatory dysfunction ater
      incomplete SCI.
Spinal cord injury (SCI) produces bone, muscle, and neural impairments that increase fracture
      risk and impede recovery of physical function. Locomotor training (LT) increases muscle size
      and promotes recovery of muscle function and walking in some persons with incomplete SCI. It
      is unknown if testosterone replacement therapy (TRT) improves these factors in men who have
      walking dysfunction and low testosterone after incomplete SCI. In addition, the combined
      effects of LT plus TRT remain unknown in men with incomplete SCI.

      For this pilot study, men with chronic incomplete SCI involving spinal level L1 or above or
      complete SCI involving spinal levels T2-L1, with upper motor neuron signs, who have low
      testosterone and walking dysfunction will receive 6-months of TRT alone or TRT with LT. TRT
      injections will be given weekly. LT will involve 35 sessions of treadmill walking with
      assistance and overground walking (4 sessions per week) during the initial 2-3 months of TRT.
      Participants will be assessed at study entry and at 1-6 month intervals thereafter. Testing
      will include measurements such as a magnetic resonance imaging (MRI) scans, dual energy x-ray
      absorptiometry (DEXA) scan, and muscle performance and walking tests. Participants will also
      undergo safety tests, including physical exams, electrocardiogram (ECG), prostate digital
      rectal exam, and blood tests to assess hematocrit, liver enzymes (AST and ALT), prostate
      specific antigen (PSA), and other health markers. The treatment groups will be compared with
      a non-treatment control group comprised of men with incomplete or complete SCI who receive no
      treatment. Participants enrolled in the non-treatment control group will undergo the same
      tests described above.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: change in thigh muscle cross-sectional area
time frame: baseline, 3 months, 6 months
description: change in thigh muscle cross-sectional area assessed via MRI
measure: change in 6 min walk test (6MWT)
time frame: baseline, 1 month, 3 months, 6 months
description: change in distance covered on 6MWT
measure: change in distal femur bone mineral density
time frame: baseline, 3 months, 6 months
description: change in distal femur bone mineral density (BMD) assessed via DEXA
measure: change in knee extensor peak torque
time frame: baseline, 3 months, 6 months
description: change in knee extensor peak torque assessed via dynamometry
measure: change in 10m walk test (10mWT)
time frame: baseline, 1 month, 3 months, 6 months
description: change in time to complete 10mWT
measure: change in bone resorption marker
time frame: baseline, 3 months, 6 months
description: change in circulating bone resorption marker
measure: change in bone formation marker
time frame: baseline, 3 months, 6 months
description: change in circulating bone formation marker
arm group label: testosterone enanthate
arm group type: Experimental
description: Testosterone enanthate via i.m. injection (100 mg/week)
arm group label: locomotor training, testosterone enanthate
arm group type: Experimental
description: Treadmill and overground walking training and testosterone enanthate via i.m. injection (100 mg/week)
arm group label: non-interventional control
arm group type: No Intervention
description: Non-interventional control group
intervention type: Drug
intervention name: Testosterone Enanthate
description: Subjects receive testosterone (100 mg/week) by intramuscular injection
arm group label: locomotor training, testosterone enanthate
arm group label: testosterone enanthate
other name: delatestryl
intervention type: Behavioral
intervention name: Locomotor Training
description: Subjects receive locomotor training (4 sessions/week for 2-3 months)
arm group label: locomotor training, testosterone enanthate
other name: Treadmill training and overground walking
criteria: 
gender: Male
gender based: Yes
gender description: Participants must be male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Joshua F Yarrow, PhD
role: Principal Investigator
affiliation: North Florida/South Georgia Veterans Health System
last name: Joshua F Yarrow, PhD
phone: (352) 548-6477
email: joshua.yarrow@va.gov
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: North Florida Foundation for Research and Education
investigator full name: Joshua Yarrow
investigator title: Research Health Scientist
mesh term: Spinal Cord Injuries
mesh term: Nervous System Diseases
mesh term: Central Nervous System Diseases
mesh term: Gait Disorders, Neurologic
mesh term: Spinal Cord Diseases
mesh term: Trauma, Nervous System
mesh term: Genital Diseases
mesh term: Genital Diseases, Male
mesh term: Hypogonadism
mesh term: Endocrine System Diseases
mesh term: Gonadal Disorders
mesh term: Mobility Limitation
mesh term: Wounds and Injuries
mesh term: Spinal Injuries
mesh term: Methyltestosterone
mesh term: Testosterone
mesh term: Testosterone undecanoate
mesh term: Testosterone enanthate
mesh term: Testosterone 17 beta-cypionate
sharing ipd: Yes
ipd description: Data will be shared according to the requirements described by the Department of Veterans Affairs, Office of Research & Development.
ipd time frame: Data will be shared according to the requirements described by the Department of Veterans Affairs, Office of Research & Development.
ipd access criteria: Data will be shared according to the requirements described by the Department of Veterans Affairs, Office of Research & Development.