Locomotor Training With Testosterone to Promote Bone and Muscle Health

  • STATUS
    Recruiting
  • days left to enroll
    61
  • participants needed
    21
  • sponsor
    North Florida Foundation for Research and Education
Updated on 14 October 2022
body mass index
anemia
replacement therapy
testosterone
deficit
testosterone level
spasticity
spinal cord
spinal cord disorder
incomplete spinal cord injury
locomotor training

Summary

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.

Description

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.

Details
Condition Spinal Cord Injury, Spinal Cord Injuries, Trauma, Nervous System, Wounds and Injury, Central Nervous System Diseases, Spinal Cord Diseases, Gonadal Disorders, Endocrine System Diseases, Hypogonadism, Genital Diseases, Male, Spinal Cord Trauma, Injuries, Spinal Cord, Walking, Difficulty, Gait Disorders, Neurologic, Locomotion Disorder, Neurologic, Wounds and Injuries, Nervous System Diseases, Testosterone Deficiency, Androgen Deficiency, Hormone Deficiency
Treatment testosterone enanthate, Locomotor Training
Clinical Study IdentifierNCT04460872
SponsorNorth Florida Foundation for Research and Education
Last Modified on14 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Men >18 years of age
Diagnosis of an incomplete SCI involving spinal segments L1 or above or a clinically complete SCI involving spinal segments T2-L1, with upper motor neuron injury signs (i.e., spasticity, hypertonicity) for >12-months
Low serum total testosterone (<300 ng/dL), bioavailable testosterone (<110 ng/dL), or free testosterone (<46 pg/mL or <4.6 ng/dL)
Presence of one or more sign or symptom that may be related to low testosterone, including: loss of body hair or reduced shaving, very small testes (<6 mL), reduced sexual desire (libido) and activity, decreased spontaneous erections (e.g., morning erections) or erectile dysfunction, breast discomfort or gynecomastia, height loss, low-trauma fracture, or low BMD, hot flushes or sweats, decreased energy, motivation, initiative, or self-confidence, fatigue or irritability, feeling sad or blue, having a depressed mood, or having a persistent low-grade depressive disorder, poor concentration or memory, sleep disturbances or increased sleepiness, mild unexplained anemia (normochromic or normocytic), reduced muscle bulk, strength, or physical performance, Increased body fat or body mass index, any other sign or symptom commonly associated with low testosterone
Locomotor dysfunction, definted as self-selected walking pace ≤1.0 m/s on a 10mWT, either with or without gait devices or braces and with or without assistance, or as self-selected walking pace >1.0 m/s with reliance on a gait device or brace or with highly compensated movement impairments, as identified by a trained observer
Diagnosis of first time SCI including etiology from trauma, vascular, or orthopedic pathology
Medically-stable condition that is asymptomatic for conditions that will interfere with the study participation
Willingness to administer TRT as instructed by the study staff and to abide by study protocol
Documented approval from the study physician verifying medical status

Exclusion Criteria

Currently participating in another research protocol that may influence study outcomes
Mental state that precludes understanding the study protocol
Life expectancy <12-months
History of or current congenital SCI (e.g., Chiari malformation, myelomeningocele, intraspinal neoplasm, Frederich's ataxis) or other degenerative spinal disorder (e.g., spinocerebellar degeneration) that may complicate study procedures
Multiple sclerosis, amyotrophic lateral sclerosis, or other neurologic impairment or injury
Current prostate, breast, or other organ cancer or a history of prostate or breast cancer
Any other diagnosed or treated cancer within the past 24-months, with the exceptions of basal or squamous cell carcinoma of the skin that has been successfully treated
Serum prostate-specific antigen (PSA) >3.0 ng/mL [men treated with 5-alpha reductase inhibitors (e.g., finasteride or dutasteride) are eligible to participate if PSA values are ≤1.5 ng/mL]
Prostate nodule or induration noted on digital rectal exam (DRE) during screening that tests positive for prostate cancer
Currently seeking fertility or expected during the duration of the study
Gynecomastia
Hematocrit (HCT) >49%
Any major cardiovascular (CV) event within the last 12-months (defined as a history of acute myocardial infarction, any cardiac revascularization procedure including angioplasty, stenting, or coronary artery bypass grafting, revascularization of the carotid or middle cerebral artery or procedures to treat critical limb ischemia, or hospitalization due to unstable angina, transient ischemic attack, stroke, or peripheral vascular disease)
Angina that is not controlled on a current medical regimen (Canadian class II, III, or IV)
Poorly compensated congestive heart failure (NYHA class III or IV)
Poorly controlled hypertension (consistently measured systolic BP ≥160 mmHg or diastolic BP ≥100 mmHg), while on medications
Poorly controlled arrhythmia of any type
Severe valvular heart disease
Baseline electrocardiogram (ECG) findings such as left bundle branch block or marked ECG abnormalities that would preclude serial screening evaluations for occult ischemic events
History of unprovoked deep venous thrombosis (DVT), unprovoked pulmonary embolism, history of recurrent DVT or known thrombophilia
LDL cholesterol >160 mg/dL with history of any major CV event, defined above, within the last 12-months
Major non-CV surgery (e.g., major abdominal or thoracic procedure) within 90-days prior to screening and/or a major surgery scheduled at the time of screening
Liver enzymes (AST or ALT) >1.5 times the normal upper limit
Severe or end-stage chronic kidney disease documented by estimated glomerular filtration rate (eGFR) <30 mL/min
Diagnosed, but untreated severe obstructive sleep apnea
Lower extremity fracture in the last 12-months (exclusion criterion for participation in LT+TRT group only)
Femoral neck, total hip, or lumbar spine t-score below -2.5 or distal femur BMD <0.70 g/cm2, assessed via DEXA at screening (exclusion criterion for participation in LT+TRT group only)
Current anticoagulant therapy (contraindication for i.m. injections)
Use of any of the following pharmacologic agents in the previous 90-days: any TRT formulation, any compounded or over-the-counter androgenic hormones or androgen precursors, clomiphene, aromatase inhibitors, anti-estrogen or estrogen treatment, or growth hormone
Use of anti-resorptive or bone anabolic drug therapy in the previous 180-days
Acute use (>5-days) of any opioids (e.g., oxycodone, hydrocodone, etc) or systemic glucocorticoids >7.5 mg/d prednisone equivalent (e.g., hydrocortisone 30 mg, methylprednisolone 6 mg, or dexamethasone 1.2 mg) within 1-week before screening visit, except men who are taking these medications for a chronic condition and are anticipated to continue treatment for the study duration
Known allergy to any component of the TRT formulation (e.g., sesame oil)
Any other condition, therapy, lab abnormality, medical or psychiatric conditions, or reason that might pose a risk to the participant, make participation not in the person's best interest, confound the study results (e.g., inability to comply with study requirements), make the participant unsuitable to receive study intervention, or interfere with the person's ability to participate for the entire study duration
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note