Higher-Than-Replacement Testosterone Plus Finasteride Treatment After SCI
Overview
- Phase
- Phase 2
- Intervention
- Testosterone Enanthate
- Conditions
- Spinal Cord Injury
- Sponsor
- VA Office of Research and Development
- Enrollment
- 33
- Locations
- 2
- Primary Endpoint
- Absolute Change in Walking Speed
- Status
- Terminated
- Last Updated
- 2 years ago
Overview
Brief Summary
The purpose of this study is to determine whether testosterone plus finasteride treatment will improve musculoskeletal health, neuromuscular function, body composition, and metabolic health in hypogonadal men who have experienced ambulatory dysfunction subsequent to incomplete spinal cord injury. The investigators hypothesize that this treatment will improve bone mineral density, enhance muscle size and muscle function, and improve body composition, without causing prostate enlargement.
Detailed Description
Men with spinal cord injury (SCI) experience a high prevalence of hypogonadism which influences the neural, muscular, skeletal, and body composition deficits that occur after injury. It remains unknown whether testosterone administration improves bone mineral density, muscle mass and muscle function, and body composition / metabolic health in hypogonadal men who have experienced ambulatory dysfunction subsequent to incomplete spinal cord injury. In addition, it is unknown whether testosterone or the 5-alpha reduced metabolite dihydrotestosterone (an endogenous metabolite of testosterone) mediate effects in these and other tissues. For this study hypogonadal men with motor incomplete spinal cord injury who present with ambulatory dysfunction will be randomized to receive testosterone plus the 5-alpha reductase inhibitor finasteride or a placebo treatment for 12 months. Testosterone or placebo injection will be administered weekly; finasteride or placebo will be administered daily. Participants will be assessed at study entry and at 1-6 month intervals thereafter. Assessments will include measurements such as a dual energy x-ray absorptiometry (DEXA) scan, MRI scan, and muscle performance tests. Participants will also have several safety tests, including electrocardiogram (EKG) for cardiac electrophysiology, prostate digital rectal exam and prostate ultrasound sizing for prostate health, and blood tests to assess hematocrit, liver enzymes (AST and ALT), prostate specific antigen (PSA), cholesterol, and other health markers.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male \> 18 years of age
- •Traumatic, vascular, or orthopedic spinal cord injury between C2-L3 \>12 months prior to enrollment
- •Motor incomplete spinal cord (AIS C/D)
- •Ambulatory dysfunction
- •Medically stable condition that is asymptomatic for bladder infection, decubiti, cardiopulmonary disease, or other significant medical conditions
- •Serum total testosterone (\<325 ng/dL) or bioavailable testosterone (\<70 ng/dL)
Exclusion Criteria
- •Currently participating in another research protocol that may influence study outcomes
- •Life expectancy \<1 year
- •History of or current congenital spinal cord injury or other degenerative spinal disorder
- •Diagnosis of multiple sclerosis, amyotrophic lateral sclerosis, or other neurologic impairment/injury
- •History of venous thromboembolism within the last 6 months, specifically deep venous thromboembolism and pulmonary embolism, history of recurrent venous thromboembolism or know hereditary thrombophilia
- •Poorly compensated or uncontrolled cardiovascular disease
- •Any major cardiovascular 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, hospitalization due to unstable angina, transient ischemic attack, or stroke)
- •Any angina that is not controlled on a current medical regimen (Canadian class II, III, or IV)
- •New York Heart Association (NYHA) class III or IV congestive heart failure
- •Systolic blood pressure \>160 mmHg or diastolic blood pressure \>100 mm Hg
Arms & Interventions
testosterone enanthate, finasteride
Testosterone enanthate via i.m. injection (125 mg/week) and finasteride orally (5 mg/day)
Intervention: Testosterone Enanthate
testosterone enanthate, finasteride
Testosterone enanthate via i.m. injection (125 mg/week) and finasteride orally (5 mg/day)
Intervention: Finasteride
placebo treatment
Placebo via i.m. injection (once weekly) and placebo pill orally (daily)
Intervention: Placebo injection
placebo treatment
Placebo via i.m. injection (once weekly) and placebo pill orally (daily)
Intervention: Placebo pill
Outcomes
Primary Outcomes
Absolute Change in Walking Speed
Time Frame: Baseline, 6 months, 12 months
Absolute change in 10 m walking speed
Percent Change in Hip Bone Mineral Density
Time Frame: Baseline, 6 months, 12 months
Percent change in total hip bone mineral density of the non-dominant limb assessed via dual-energy X-ray absorptiometry (DXA)
Percent Changes in Muscle Cross-Sectional Area
Time Frame: Baseline, 6 months, 12 months
Percent Change in thigh (knee extensors) muscle cross-sectional area of the non-dominant limb assessed via MRI
Percent Change in Total Body Fat
Time Frame: Baseline, 6 months, 12 months
Percent change in total body fat assessed via dual-energy x-ray absorptiometry (DXA)
Secondary Outcomes
- Percent Change in Neuromuscular Function(Baseline, 6 months, 12 months)
- Percent Change in Visceral Fat(Baseline, 6 months, 12 months)