Testosterone Plus Finasteride Treatment After Spinal Cord Injury

Condition(s) targeted: Spinal Cord Injury; Spinal Cord Injuries; Trauma, Nervous System; Wounds and Injuries; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases; Gonadal Disorders; Endocrine System Diseases; Hypogonadism; Genital Diseases, Male

Intervention: testosterone enanthate, finasteride (Drug); placebo (Other)

Phase: Phase 2

Status: Not yet recruiting

Sponsored by: Department of Veterans Affairs

Official(s) and/or principal investigator(s):
Joshua F. Yarrow, PhD, Principal Investigator, Affiliation: North Florida/South Georgia Veterans Health System, Gainesville, FL

Overall contact:
Joshua F Yarrow, PhD, Phone: (352) 376-1611, Ext: 6477, Email: joshua.yarrow@va.gov

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 men who have experienced ambulatory dysfunction subsequent to incomplete spinal cord injury. We hypothesize that this treatment will improve bone mineral density, enhance muscle size and muscle function, and improve body composition, without causing prostate enlargement.

Official title: Higher-Than-Replacement Testosterone Plus Finasteride Treatment After SCI

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Primary outcome: Change in body composition

Secondary outcome:

Change in neuromuscular function

Change in metabolic profile

Changes in muscle cross-sectional area

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), and cholesterol.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Male.

Criteria:

Inclusion Criteria:

- Male > 18 years of age

- Traumatic, vascular, or orthopedic spinal cord injury between C4-T7 >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

- Poorly compensate or uncontrolled cardiovascular disease

- Acute myocardial infarction within the last 6 months

- Any cardiac revascularization procedure within the last 6 months, including

angioplasty and coronary bypass grafting

- Any cardiovascular-related hospitalization within the last 6 months

- Any other major cardiovascular event within the last 6 months

- 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 >90 mm Hg

- Poorly controlled arrhythmia

- Severe valvular disease

- History of stroke

- Baseline EKG findings (e. g. left bundle branch block) or marked EKG abnormalities

that would preclude serial screening for occult ischemic events

- History of or current prostate, breast, or other organ cancer

- Serum prostate-specific antigen (PSA) >3. 0 ng/ml

- Hematocrit >47%

- Liver enzymes (AST / ALT) outside normal limits

- Creatinine >1. 4 mg/dL

- Mental state that precludes understanding of the protocol

- Diagnosed, but untreated sleep apnea

- Spinal nutrition screening tool score > 15

- Presence of non-MRI compatible implants or severe claustrophobia that precludes MRI

testing

- Current anticoagulant therapy

- Use of any of the following pharmacologic agents in the previous 3 months

(testosterone, leuprolide, androgenic hormones, growth hormone, oral androgen precursors, 5-alpha reductase or aromatase inhibitors)

- Use of anti-resorptive or bone anabolic drug therapy in the previous 6 months

Joshua F Yarrow, PhD, Phone: (352) 376-1611, Ext: 6477, Email: joshua.yarrow@va.gov

North Florida/South Georgia Veterans Health System, Gainesville, FL, Gainesville, Florida 32608, United States; Not yet recruiting
Joshua F Yarrow, PhD, Phone: 352-376-1611, Ext: 6477, Email: joshua.yarrow@va.gov
Joshua F. Yarrow, PhD, Principal Investigator

Starting date: June 2015
Last updated: March 11, 2015