Actively Recruiting

Phase 2
Age: 18Years +
MALE
NCT04460872

Locomotor Training With Testosterone to Promote Bone and Muscle Health After Spinal Cord Injury

Led by North Florida Foundation for Research and Education · Updated on 2025-05-06

21

Participants Needed

2

Research Sites

282 weeks

Total Duration

On this page

Sponsors

N

North Florida Foundation for Research and Education

Lead Sponsor

N

North Florida/South Georgia Veterans Health System

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Locomotor Training With Testosterone to Promote Bone and Muscle Health After Spinal Cord Injury

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Men >18 years of age
  • Diagnosis of incomplete SCI involving spinal segments L1 or above or clinically complete SCI involving spinal segments T2-L1 with upper motor neuron signs for >60 days
  • 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 signs or symptoms related to low testosterone, such as reduced body hair, small testes (<6 mL), reduced sexual desire, erectile dysfunction, gynecomastia, height loss, low-trauma fracture or low bone mineral density, hot flushes or sweats, low energy or motivation, fatigue, depressed mood, poor concentration, sleep disturbances, mild anemia, reduced muscle bulk or strength, increased body fat, or other common low testosterone symptoms
  • Locomotor dysfunction defined as self-selected walking pace ≤1.0 m/s on a 10-meter walk test with or without gait devices or assistance, or >1.0 m/s with reliance on gait devices or compensated movement impairments
  • First-time SCI including trauma, vascular, or orthopedic causes
  • Medically stable condition without symptoms interfering with study participation
  • Willingness to administer TRT as instructed and abide by study protocol
  • Documented approval from study physician verifying medical status
Not Eligible

You will not qualify if you...

  • Currently participating in another research protocol that may influence study outcomes
  • Mental state preventing understanding of study protocol
  • Life expectancy less than 12 months
  • History or current congenital SCI or other degenerative spinal disorders that may complicate procedures
  • Multiple sclerosis, amyotrophic lateral sclerosis, or other neurologic impairments
  • Current or history of prostate, breast, or other organ cancer within past 24 months (except treated basal or squamous skin carcinoma)
  • Prostate-specific antigen (PSA) >3.0 ng/mL unless treated with 5-alpha reductase inhibitors with PSA ≤1.5 ng/mL
  • Prostate nodule or induration with positive cancer test on digital rectal exam
  • Currently seeking or expected fertility during study
  • Gynecomastia
  • Hematocrit >49%
  • Major cardiovascular events within past 12 months or uncontrolled angina, heart failure, hypertension, arrhythmia, severe valvular disease
  • ECG abnormalities precluding evaluations
  • History of unprovoked deep venous thrombosis, pulmonary embolism, or known thrombophilia
  • LDL cholesterol >160 mg/dL with recent major cardiovascular event
  • Major surgery within 90 days prior or scheduled at screening
  • Elevated liver enzymes (AST or ALT >1.5 times upper limit)
  • Severe or end-stage chronic kidney disease (eGFR <30 mL/min)
  • Diagnosed untreated severe obstructive sleep apnea
  • Lower extremity fracture in last 12 months (for LT+TRT group only)
  • Low bone mineral density below specified thresholds (for LT+TRT group only)
  • Current anticoagulant therapy
  • Use of TRT, androgenic hormones, or related drugs within past 90 days
  • Use of anti-resorptive or bone anabolic therapies within past 180 days
  • Recent acute use of opioids or systemic glucocorticoids except for chronic conditions
  • Known allergy to TRT formulation components
  • Any other condition or reason that poses risk, interferes with participation, or affects study results

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

North Florida/South Georgia Veterans Health System

Gainesville, Florida, United States, 32608

Actively Recruiting

2

Brooks Rehabilitation

Jacksonville, Florida, United States, 32216

Actively Recruiting

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Research Team

J

Joshua F Yarrow, PhD

CONTACT

D

Dana M Otzel, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

3

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