The Use of Anabolic Steroids to Improve Function After Spinal Cord Injury - Full Text View

Sponsor:	Department of Veterans Affairs
Information provided by:	Department of Veterans Affairs
ClinicalTrials.gov Identifier:	NCT00223769

Purpose

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.

Condition	Intervention
Spinal Cord Injury	Drug: Oxandrolone

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	The Use of Oxandrolone to Improve Function in Persons With Chronic Spinal Cord Injury

Resource links provided by NLM:

MedlinePlus related topics: Spinal Cord Injuries

Drug Information available for: Oxandrolone

U.S. FDA Resources

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:

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:

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

Estimated Enrollment:	40
Study Start Date:	January 2004
Study Completion Date:	May 2006

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.

Eligibility

Ages Eligible for Study:	20 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00223769

Locations

United States, Florida
Miami Veterans Affairs Medical Center
Miami, Florida, United States, 33125

Sponsors and Collaborators

Department of Veterans Affairs

Investigators

Principal Investigator:

Kresimir Banovac, PhD MD

VA Spinal Cord Injury Service

More Information

Additional Information:

Center of Excellence in Functional Recovery in Chronic Spinal Cord Injury This link exits the ClinicalTrials.gov site

Publications:

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

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.

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.

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

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.

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.

ClinicalTrials.gov Identifier:	NCT00223769 History of Changes
Other Study ID Numbers:	B2656C
Study First Received:	September 13, 2005
Last Updated:	February 12, 2008
Health Authority:	United States: Federal Government

Keywords provided by Department of Veterans Affairs:

oxandrolone
oxandrin
lean body mass
functional recovery
resistance training

Additional relevant MeSH terms:

Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Oxandrolone

Anabolic Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Androgens

ClinicalTrials.gov processed this record on February 09, 2012