Clinical trial NCT00223769: The Use of Anabolic Steroids to Improve Function After Spinal Cord Injury
Official title: The Use of Oxandrolone to Improve Function in Persons With Chronic Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injury
Keywords: oxandrolone
oxandrin
lean body mass
functional recovery
resistance training
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2005-09-22
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Part-A: lean body mass, upper extremity muscle strength. Measures are made at baseline, 12-weeks (end of intervention), and at 24-weeks.
measure: Part-B: respiratory function, efficency of ambulaton (speed and quality of gait). Measures are made at baseline,
measure: 12-weeks (end of intervention), and at 24-weeks.
Secondary outcomes:
measure: Part-A: maximum VO2/respiratory function, functional status, safety, quality of life, community
measure: re-integration.
measure: Part-B: upper extremity strength, lean body mass, functional status, safety, quality of life, community
Other outcomes:
Locations:
city: Miami
country: United States
facility: Miami Veterans Affairs Medical Center
state: Florida
Study officials:
affiliation: VA Spinal Cord Injury Service
name: Kresimir Banovac, PhD MD
role: PRINCIPAL_INVESTIGATOR
References:
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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. doi: 10.1177/014860719201600111.
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.
citation: Cardus D, McTaggart WG. Body sodium and potassium in men with spinal cord injury. Arch Phys Med Rehabil. 1985 Mar;66(3):156-9.
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. doi: 10.1097/00005768-200105000-00005.
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.