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

Spinal Cord Injury Clinical Trial

Official title:

The Use of Oxandrolone to Improve Function in Persons With Chronic Spinal Cord Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00223769
• Other study ID #: B2656C
• Status: Completed
• Phase: N/A
• First received: September 13, 2005
• Last updated: February 12, 2008
• Start date: January 2004
• Est. completion date: May 2006

Study information

• Verified date: May 2006
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury

Intervention

Drug:
• Oxandrolone

Locations

Country	Name	City	State
United States	Miami Veterans Affairs Medical Center	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (6)

Barton RG. Nutrition support in critical illness. Nutr Clin Pract. 1994 Aug;9(4):127-39. Review. — View Citation

Cardús D, McTaggart WG. Body sodium and potassium in men with spinal cord injury. Arch Phys Med Rehabil. 1985 Mar;66(3):156-9. — View Citation

Furuno K, Goodman MN, Goldberg AL. Role of different proteolytic systems in the degradation of muscle proteins during denervation atrophy. J Biol Chem. 1990 May 25;265(15):8550-7. — View Citation

Jacobs PL, Mahoney ET, Nash MS, Green BA. Circuit resistance training in persons with complete paraplegia. J Rehabil Res Dev. 2002 Jan-Feb;39(1):21-8. — View Citation

Jacobs PL, Nash MS, Rusinowski JW. Circuit training provides cardiorespiratory and strength benefits in persons with paraplegia. Med Sci Sports Exerc. 2001 May;33(5):711-7. — View Citation

Kearns PJ, Thompson JD, Werner PC, Pipp TL, Wilmot CB. Nutritional and metabolic response to acute spinal-cord injury. JPEN J Parenter Enteral Nutr. 1992 Jan-Feb;16(1):11-5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Part-A: lean body mass, upper extremity muscle strength. Measures are made at baseline, 12-weeks (end of intervention), and at 24-weeks.
Primary	Part-B: respiratory function, efficency of ambulaton (speed and quality of gait). Measures are made at baseline,
Primary	12-weeks (end of intervention), and at 24-weeks.
Secondary	Part-A: maximum VO2/respiratory function, functional status, safety, quality of life, community
Secondary	re-integration.
Secondary	Part-B: upper extremity strength, lean body mass, functional status, safety, quality of life, community

External Links

•   Center of Excellence in Functional Recovery in Chronic Spinal Cord Injury