AzTrials
AzTrials

Spinal Cord InjuryNCT00223769

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

A study testing Oxandrolone in people with Spinal Cord Injury, run by US Department of Veterans Affairs at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 20 to 70 years
Conditions the study is for
Spinal Cord Injury
What is being tested?
Oxandrolone
How many people
40 participants
Where
1 siteUnited States
Study dates
Jan 2004to May 2006
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 14Show fewer
  • 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

Who cannot join

  • Active medical problems including:
  • Uncontrolled diabetes
  • Cardiovascular disease
  • Cancer
  • Liver disease
  • Hypocalcaemia
Show all 11Show fewer
  • Nephritic syndrome
  • HIV/AIDS
  • Pressure ulcers of grade 3 or 4
  • Shoulder pathology
  • Pregnancy

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Miami Veterans Affairs Medical Center

    Miami, Florida, 33125

Other trials in United States

About this study

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

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.

Being tested
Oxandrolone
Keywords
oxandrolone, oxandrin, lean body mass, functional recovery, resistance training
Medical subject headings
Spinal Cord Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OxandroloneDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  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 (3)

  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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2005 (estimated)
  2. Study startJan 2004
  3. Study completionMay 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
Double blind
Enrolment
40 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00223769
Sponsor's protocol ID
B2656C
Status last verified
May 2006
First submitted
13 Sep 2005
Last updated
13 Feb 2008
Results posted
No

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

Questions about this trial

What is this clinical trial studying?

A study testing Oxandrolone in people with Spinal Cord Injury, run by US Department of Veterans Affairs at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Feb 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part-A: lean body mass, upper extremity muscle strength. Measures are made at baseline, 12-weeks (end of intervention), and at 24-weeks.. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00223769, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2008.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in