Spinal Cord Injury
Conditions
Keywords
oxandrolone, oxandrin, lean body mass, functional recovery, resistance training
Brief summary
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
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.
Interventions
DRUGOxandrolone
Sponsors
US Department of Veterans Affairs
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | 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 | — |
Countries
United States
Outcome results
None listed