The Use of Anabolic Steroids to Improve Function After Spinal Cord Injury

Study Overview
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Brief Summary
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The purpose of this study is to determine the effect of oxandrolone on the function and quality of life of patients with chronic spinal cord injury.

Detailed Description
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Spinal cord injury results in significant loss of muscle mass. Oxandrolone, a derivative of testosterone, is an anabolic steroid shown to promote gain in body weight and muscle mass after trauma, severe illness, surgery, burns, and stress. To date there are no studies that have evaluated the effect of oxandrolone in persons with chronic spinal cord injury. This study will assess the effect of oxandrolone on strength, metabolic rate, lean body mass, pulmonary function, and ambulation in persons with chronic SCI. This study has the potential to yield valuable information concerning the use of oxandrolone after SCI.

Official Title
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The Use of Oxandrolone to Improve Function in Persons With Chronic Spinal Cord Injury

Conditions
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Spinal Cord Injury

Intervention / Treatment
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* Drug: Oxandrolone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Part-A Diagnosed with a traumatic injury to spinal cord Motor complete injury at level of C5 to T12 Date of injury at least one year prior to enrollment Sufficient upper body strength to participate in a 12-week resistance training program with accommodation for disability in hand strength and/or grasping Lean body mass in lower extremities less than 90% of normal as determined by DEXA scan Willingness to take study medication for 12 weeks twice a day by mouth Part-B: Diagnosed with a traumatic injury to the spinal cord Motor incomplete injury at any level Date of injury at least one year prior to enrollment Lean body mass in lower extremities less than 90% of normal as determined by DEXA scan Ability to stand independently with or without the aid of assistive device(s) Willingness to take study medication for 12 weeks twice a day by mouth Exclusion Criteria: Active medical problems including: Uncontrolled diabetes Cardiovascular disease Cancer Liver disease Hypocalcaemia Nephritic syndrome HIV/AIDS Pressure ulcers of grade 3 or 4 Shoulder pathology Pregnancy

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Oxandrolone|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Part-A: lean body mass, upper extremity muscle strength. Measures are made at baseline, 12-weeks (end of intervention), and at 24-weeks. |  |  | 
| Part-B: respiratory function, efficency of ambulaton (speed and quality of gait). Measures are made at baseline, |  |  | 
| 12-weeks (end of intervention), and at 24-weeks. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Part-A: maximum VO2/respiratory function, functional status, safety, quality of life, community |  |  | 
| re-integration. |  |  | 
| Part-B: upper extremity strength, lean body mass, functional status, safety, quality of life, community |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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oxandrolone, oxandrin, lean body mass, functional recovery, resistance training