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

Not Applicable

Completed

• Conditions: Spinal Cord Injury

• Registration Number: NCT00223769
• Lead Sponsor: US Department of Veterans Affairs

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.

Study Timeline

• Study Start: 2004-01
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-22
• Status Verified: 2006-05
• Study Completion: 2006-05
• Last Update Submitted: 2008-02-12
• Last Update Posted: 2008-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Miami Veterans Affairs Medical Center; 🇺🇸 Miami, Florida, United States