Central Nervous System Diseases Clinical Trial
NCT02248701
| Phase 2
| Interventional
This study has recruited 12 Participants
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.
Details for the study
Brief Title
Testosterone Plus Finasteride Treatment After Spinal Cord Injury
Official Title
Higher-Than-Replacement Testosterone Plus Finasteride Treatment After SCI
Brief Summary
The purpose of this study is to determine whether testosterone plus finasteride treatment
<br /> will improve musculoskeletal health, neuromuscular function, body composition, and metabolic
<br /> health in hypogonadal men who have experienced ambulatory dysfunction subsequent to
<br /> incomplete spinal cord injury. The investigators hypothesize that this treatment will improve
<br /> bone mineral density, enhance muscle size and muscle function, and improve body composition,
<br /> 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.
Treatments and/or Procedures
Placebo pill
Subjects receive placebo pill (daily) orally
Placebo injection
Subjects receive placebo (weekly) by intramuscular injection
Finasteride
Subjects receive finasteride (5 mg/day) orally
Testosterone enanthate
Subjects receive testosterone (125 mg/week) by intramuscular injection
Outcome Measures
Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.
Primary
Changes in Muscle Cross-Sectional Area
Change in thigh muscle cross-sectional area assessed via MRI
Primary
Change in Total Body Fat
Change in total body fat assessed via DXA
Primary
Change in Walking Speed
Change in 10 m walking speed
Primary
Change in Hip Bone Mineral Density
Change in hip bone mineral density assessed via dual-energy X-ray absorptiometry (DXA)
Secondary
Change in Neuromuscular Function
Change in thigh muscle force production assessed via dynamometry
Secondary
Change in Visceral Fat
Change in visceral fat mass assessed via DXA
Study 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
- Poorly controlled arrhythmia
- Severe valvular disease
- LDL cholesterol >160 mg/dl with known history of any major cardiovascular event, as
defined above, within the last 12 months
- Baseline EKG findings (e.g. left bundle branch block) or marked EKG abnormalities that
would preclude serial screening for occult ischemic events
- Current prostate, breast, or other organ cancer
- History of prostate, breast, or other organ cancer, with the exceptions of completely
resolved basal or squamous cell carcinoma for a duration of >24 months or completely
resolved melanoma for a duration of >24 months
- Serum prostate-specific antigen (PSA) >3.0 ng/ml
- History of benign prostate enlargement (BPE) >40cc, evaluated via TRUS
- Hematocrit >47%
- Liver enzymes (AST / ALT) above normal upper limit
- Creatinine >1.4 mg/dL
- Serum calcium >10.5 mg/dL
- Gynecomastia
- Mental state that precludes understanding of the protocol
- Diagnosed, but untreated moderate or severe sleep apnea
- Spinal nutrition screening tool score >15
- 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
- Known allergy to sesame oil
