A Multisite, Double-blind, Randomized Controlled Trial Comparing Body Composition, Muscle, and Bone Changes to TestosteRone Therapy With or Without Finasteride After Spinal Cord Injury: TRT-SCI Trial

Summary

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.

Description

Eligibility

Age range

18+ years

Sex

Male

Healthy volunteers

No

Interventions

• Drug
  testosterone cypionate

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

• Drug
  finasteride

  Participants receive finasteride (5 mg/day) orally

• Drug
  placebo injection

  Participants receive placebo (weekly) by intramuscular injection

• Drug
  placebo pill

  Participants receive placebo pill (daily) orally

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