Testosterone Plus Finasteride Treatment After Spinal Cord Injury

Overview

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.

Full Title of Study: “Higher-Than-Replacement Testosterone Plus Finasteride Treatment After SCI”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: August 13, 2021

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.

Interventions

  • Drug: Testosterone Enanthate
    • Subjects receive testosterone (125 mg/week) by intramuscular injection
  • Drug: Finasteride
    • Subjects receive finasteride (5 mg/day) orally
  • Drug: Placebo injection
    • Subjects receive placebo (weekly) by intramuscular injection
  • Drug: Placebo pill
    • Subjects receive placebo pill (daily) orally

Arms, Groups and Cohorts

  • Experimental: testosterone enanthate, finasteride
    • Testosterone enanthate via i.m. injection (125 mg/week) and finasteride orally (5 mg/day)
  • Placebo Comparator: placebo treatment
    • Placebo via i.m. injection (once weekly) and placebo pill orally (daily)

Clinical Trial Outcome Measures

Primary Measures

  • 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)
  • Absolute Change in Walking Speed
    • Time Frame: Baseline, 6 months, 12 months
    • Absolute change in 10 m walking speed

Secondary Measures

  • Percent Change in Neuromuscular Function
    • Time Frame: Baseline, 6 months, 12 months
    • Percent change in thigh (knee extensors) peak isometric torque production of the non-dominant limb assessed via dynamometry
  • Percent Change in Visceral Fat
    • Time Frame: Baseline, 6 months, 12 months
    • Percent change in visceral (android) fat mass assessed via dual-energy x-ray absorptiometry (DXA)

Participating in This Clinical Trial

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

Gender Eligibility: Male

Participants must be male

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • VA Office of Research and Development
  • Collaborator
    • University of Florida
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Joshua F Yarrow, PhD MS BS, Principal Investigator, North Florida/South Georgia Veterans Health System, Gainesville, FL
    • Dana M Otzel, PhD, Principal Investigator, North Florida/South Georgia Veterans Health System, Gainesville, FL

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.