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CompletedNCT00223769Updated Feb 13, 2008

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

An interventional study of Oxandrolone in Spinal Cord Injury, sponsored by US Department of Veterans Affairs. Completed at 1 site in United States. Open to participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2008-02-13.

Sponsored by US Department of Veterans Affairs · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
20 Years to 70 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Spinal Cord Injury

Keywords

  • oxandrolone
  • oxandrin
  • lean body mass
  • functional recovery
  • resistance training
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In context

Spinal Cord Injuries

1,948 studies on the registry are indexed under Spinal Cord Injuries; 505 are open to participants now.

This study's enrollment of 40 is above the median of 24 across 1,566 interventional studies indexed under Spinal Cord Injuries.

Browse Spinal Cord Injuries studies →

Lead sponsor

US Department of Veterans Affairs is the lead sponsor of 658 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Double
Enrollment
40 participants

Interventions

  • DrugOxandrolone
06

What researchers measure

Primary outcomes

  1. Part-A: lean body mass, upper extremity muscle strength. Measures are made at baseline, 12-weeks (end of intervention), and at 24-weeks.

  2. Part-B: respiratory function, efficency of ambulaton (speed and quality of gait). Measures are made at baseline,

  3. 12-weeks (end of intervention), and at 24-weeks.

Secondary outcomes

  1. Part-A: maximum VO2/respiratory function, functional status, safety, quality of life, community

  2. re-integration.

  3. Part-B: upper extremity strength, lean body mass, functional status, safety, quality of life, community

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Study locations

1 site
  • Miami Veterans Affairs Medical Center
    Miami, Florida 33125, United States
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References and documents

Publications

  • Barton RG. Nutrition support in critical illness. Nutr Clin Pract. 1994 Aug;9(4):127-39. doi: 10.1177/0115426594009004127. PubMed 8078451 ↗
  • 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. PubMed 1738212 ↗
  • 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. PubMed 2187867 ↗
  • Cardus D, McTaggart WG. Body sodium and potassium in men with spinal cord injury. Arch Phys Med Rehabil. 1985 Mar;66(3):156-9. PubMed 3977567 ↗
  • 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. PubMed 11323537 ↗
  • 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. PubMed 11926325 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 13, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00223769
Lead sponsor
US Department of Veterans Affairs
First posted
Sep 22, 2005
Start date
Jan 2004
Completion
May 2006
Last update
Feb 13, 2008

Study contacts

Kresimir Banovac, PhD MD
principal investigator · VA Spinal Cord Injury Service
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2006. You cannot join it, but the record below documents what was studied.

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