- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00223769
The Use of Anabolic Steroids to Improve Function After Spinal Cord Injury
February 12, 2008 updated by: US Department of Veterans Affairs
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.
Study Overview
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.
Study Type
Interventional
Enrollment
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Florida
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Miami, Florida, United States, 33125
- Miami Veterans Affairs Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Part-A: lean body mass, upper extremity muscle strength. Measures are made at baseline, 12-weeks (end of intervention), and at 24-weeks.
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Part-B: respiratory function, efficency of ambulaton (speed and quality of gait). Measures are made at baseline,
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12-weeks (end of intervention), and at 24-weeks.
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Secondary Outcome Measures
Outcome Measure |
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Part-A: maximum VO2/respiratory function, functional status, safety, quality of life, community
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re-integration.
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Part-B: upper extremity strength, lean body mass, functional status, safety, quality of life, community
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Kresimir Banovac, PhD MD, VA Spinal Cord Injury Service
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Barton RG. Nutrition support in critical illness. Nutr Clin Pract. 1994 Aug;9(4):127-39. doi: 10.1177/0115426594009004127.
- 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.
- 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. doi: 10.1097/00005768-200105000-00005.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2004
Study Completion (Actual)
May 1, 2006
Study Registration Dates
First Submitted
September 13, 2005
First Submitted That Met QC Criteria
September 13, 2005
First Posted (Estimate)
September 22, 2005
Study Record Updates
Last Update Posted (Estimate)
February 13, 2008
Last Update Submitted That Met QC Criteria
February 12, 2008
Last Verified
May 1, 2006
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- B2656C
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Spinal Cord Injury
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Taipei Veterans General Hospital, TaiwanThe Industrial Technology Research InstituteUnknownSpinal Cord Injuries | Complete Spinal Cord Injury | Incomplete Spinal Cord InjuryTaiwan
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University of FloridaEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsActive, not recruitingSCI - Spinal Cord Injury | Incomplete Spinal Cord InjuryUnited States
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Jill M. Wecht, Ed.D.Icahn School of Medicine at Mount SinaiRecruitingBlood Pressure | Spinal Cord Injuries | SCI - Spinal Cord Injury | Blood Pressure Disorders | Traumatic Spinal Cord Injury | Acute Spinal Cord Injury | Neuromodulation | Spinal Cord StimulationUnited States
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NervGen PharmaRecruitingSpinal Cord Injuries | Chronic Spinal Cord Injury | Subacute Spinal Cord InjuryUnited States
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MetroHealth Medical CenterNational Institute of Neurological Disorders and Stroke (NINDS); Case Western...RecruitingSpinal Cord Injuries | Spinal Cord Injury at C5-C7 Level | Spinal Cord Injury CervicalUnited States
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Kevin KilgoreNational Institute of Neurological Disorders and Stroke (NINDS); Case Western... and other collaboratorsRecruitingSpinal Cord Injuries | Spinal Cord Injury at C5-C7 Level | Spinal Cord Injury Cervical | Spinal Cord Injury at C5-C7 Level With Complete Lesion | Spinal Cord Injury at C5-C7 Level With Incomplete LesionUnited States
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The University of Texas Health Science Center,...TerminatedSpinal Cord Injuries | Cervical Spinal Cord Injury | Traumatic Spinal Cord CompressionUnited States
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StemCells, Inc.TerminatedStudy of Human Central Nervous System (CNS) Stem Cell Transplantation in Cervical Spinal Cord InjuryCervical Spinal Cord Injury | Spine Injury | Cervical Spine InjuryUnited States, Canada
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S.Biomedics Co., Ltd.Yonsei University; Linical Co., Ltd.RecruitingSpinal Cord Injury, Acute | Spinal Cord Injury at C5-C7 Level With Complete Lesion | Spinal Cord Injury at C4 Level With Complete LesionKorea, Republic of
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Mahidol UniversityRecruitingSpinal Cord Injury | Incomplete Spinal Cord InjuryThailand
Clinical Trials on Oxandrolone
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Thomas Jefferson UniversityNational Institute of Neurological Disorders and Stroke (NINDS)Completed
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National Institute of Neurological Disorders and...Jefferson Medical College of Thomas Jefferson UniversityCompletedTurner's SyndromeUnited States
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CJ CheilJedangNot yet recruitingPharmacokinetics
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National Institute of Diabetes and Digestive and...Completed
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Denver Health and Hospital AuthorityWithdrawnAnemia | Trauma | Functional Iron DeficiencyUnited States
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University of Southern CaliforniaActive, not recruiting
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Sunnybrook Health Sciences CentreUnited States Department of Defense; Walter Reed National Military Medical...WithdrawnTrauma Injury
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University of UtahCompleted
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US Department of Veterans AffairsTerminated
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Par Pharmaceutical, Inc.Cetero Research, San AntonioCompletedTo Determine the Bioequivalence Under Fasting ConditionsUnited States