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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
40
Miami Veterans Affairs Medical Center
Miami, Florida, United States
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.
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
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