Testosterone Therapy With or Without Finasteride After Spinal Cord Injury: TRT-SCI Trial

Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexMale
Age18+
SponsorVA Office of Research and Development

About this trial

Spinal cord injury (SCI) results in lower limb muscle loss, bone loss, and high fat mass that impede the recovery of physical function, increase bone fracture risk, and worsen health and quality of life. These deficits result from reduced activity after SCI and may be worsened by low testosterone, which is present in many men with SCI. In older men with low testosterone who do not have SCI, testosterone therapy (TRT) is known to increase muscle mass, muscle strength, and bone mineral density, and to reduce body fat. However, it is not known if TRT is effective in men with SCI. The purposes of this study are to determine the effectiveness of TRT in men who have low testosterone and difficulty walking after chronic motor incomplete SCI and to assess whether a process in the body that changes testosterone to dihydrotestosterone (DHT; another hormone that is stronger than testosterone) impacts the effectiveness of TRT in the impaired lower limbs and in other tissues after SCI. The researchers hypothesize that TRT will improve muscle and bone in the impaired limbs of men with chronic incomplete SCI and reduce fat mass, and that finasteride (a drug that blocks that blocks a process that changes testosterone to DHT) will influence prostate symptoms but not the musculoskeletal or body composition benefits produced by TRT.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Veterans eligible for care within the Veterans Health Administration (VHA)

Diagnosis of motor incomplete SCI (AIS C-D) for >24-months involving spinal segment lumbar (L)1 or above from trauma, vascular, or orthopedic pathology

Low total testosterone (<300 nanograms/decilliter [ng/dL]) and/or low free testosterone (<4.6 ng/dL)

decreased energy

Disqualifiers

Involvement in another research study that may influence outcomes

Mental state that precludes understanding the protocol

Life expectancy <12 months

History of or current congenital spinal cord injury (SCI) (e.g., Chiari malformation, myelomeningocele, intraspinal neoplasm, Friedreich's ataxia) or degenerative spinal disorder (e.g., spinocerebellar degeneration) that may complicate procedures

Trial design

Design model

Parallel

Treatments tested in this trial

  • testosterone cypionate

    Drug

    Participants receive testosterone (200 mg/q2wk) by intramuscular injection

  • finasteride

    Drug

    Participants receive finasteride (5 mg/day) orally

  • placebo injection

    Drug

    Participants receive placebo (weekly) by intramuscular injection

  • placebo pill

    Drug

    Participants receive placebo pill (daily) orally

Treatment groups

300 Participants
are divided into 3 treatment groups
Group A: testosterone, placeboExperimental treatment 2 interventions
Group B: testosterone, finasterideExperimental treatment 2 interventions
Group C: placebo treatmentPlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

Change in lower limb fat-free mass

Change from baseline in lower limb fat-free mass assessed via dual-energy X-ray absorptiometry (DXA)

Time frame
Baseline, 9 months

Secondary outcomes

1

Change in total body fat-free mass

Change from baseline in total body fat-free mass assessed via dual-energy X-ray absorptiometry (DXA)

Time frame
Baseline, 9 months
2

Change in knee extensor strength

Change from baseline in thigh (knee extensors) peak isometric torque production of the non-dominant limb assessed via dynamometry

Time frame
Baseline, 9 months
3

Change in distal femur bone mineral density

Change from baseline in distal femur areal bone mineral density of the non-dominant limb assessed via dual-energy X-ray absorptiometry

Time frame
Baseline, 9 months
4

Change in visceral adipose tissue (fat) mass

Change from baseline in visceral adipose tissue (fat) mass assessed via dual-energy X-ray absorptiometry

Time frame
Baseline, 9 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

VA Office of Research and Development

Lead sponsor

North Florida/South Georgia Veterans Health System

Collaborator

VA Eastern Colorado Health Care System

Collaborator

University of Colorado, Denver

Collaborator

James J. Peters Veterans Affairs Medical Center

Collaborator

James A. Haley Veterans Administration Hospital

Collaborator

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