Back to resultsThe Use of Anabolic Steroids to Improve Function After Spinal Cord Injury
Primary Purpose
Spinal Cord Injury
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Oxandrolone
Sponsored by
About this trial
This is an interventional treatment trial for Spinal Cord Injury focused on measuring oxandrolone, oxandrin, lean body mass, functional recovery, resistance training
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
Sites / Locations
- Miami Veterans Affairs Medical Center
Outcomes
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
Full Information
NCT ID
NCT00223769
First Posted
September 13, 2005
Last Updated
February 12, 2008
Sponsor
US Department of Veterans Affairs
1. Study Identification
Unique Protocol Identification Number
NCT00223769
Brief Title
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
2. Study Status
Record Verification Date
May 2006
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
US Department of Veterans Affairs
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury
Keywords
oxandrolone, oxandrin, lean body mass, functional recovery, resistance training
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
40 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Oxandrolone
Primary Outcome Measure Information:
Title
Part-A: lean body mass, upper extremity muscle strength. Measures are made at baseline, 12-weeks (end of intervention), and at 24-weeks.
Title
Part-B: respiratory function, efficency of ambulaton (speed and quality of gait). Measures are made at baseline,
Title
12-weeks (end of intervention), and at 24-weeks.
Secondary Outcome Measure Information:
Title
Part-A: maximum VO2/respiratory function, functional status, safety, quality of life, community
Title
re-integration.
Title
Part-B: upper extremity strength, lean body mass, functional status, safety, quality of life, community
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kresimir Banovac, PhD MD
Organizational Affiliation
VA Spinal Cord Injury Service
Official's Role
Principal Investigator
Facility Information:
Facility Name
Miami Veterans Affairs Medical Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
8078451
Citation
Barton RG. Nutrition support in critical illness. Nutr Clin Pract. 1994 Aug;9(4):127-39. doi: 10.1177/0115426594009004127.
Results Reference
background
PubMed Identifier
1738212
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.
Results Reference
background
PubMed Identifier
2187867
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.
Results Reference
background
PubMed Identifier
3977567
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.
Results Reference
background
PubMed Identifier
11323537
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.
Results Reference
background
PubMed Identifier
11926325
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.
Results Reference
background
Links:
URL
http://www.sfvafre.org
Description
Center of Excellence in Functional Recovery in Chronic Spinal Cord Injury
Learn more about this trial
The Use of Anabolic Steroids to Improve Function After Spinal Cord Injury
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