Overview

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

Status:
Completed
Trial end date:
2006-05-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
US Department of Veterans Affairs
VA Office of Research and Development
Treatments:
Oxandrolone
Criteria
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