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

US Department of Veterans Affairs (VA)

Status

Completed

Conditions

Spinal Cord Injury

Treatments

Drug: Oxandrolone

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT00223769

B2656C

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

20 to 70 years old

Volunteers

No Healthy Volunteers

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: