Status:
COMPLETED
The Use of Anabolic Steroids to Improve Function After Spinal Cord Injury
Lead Sponsor:
US Department of Veterans Affairs
Conditions:
Spinal Cord Injury
Eligibility:
All Genders
20-70 years
Phase:
NA
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, seve...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
End Date :
May 1 2006
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00223769
Start Date
January 1 2004
End Date
May 1 2006
Last Update
February 13 2008
Active Locations (1)
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1
Miami Veterans Affairs Medical Center
Miami, Florida, United States, 33125