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

This study has been completed.
Sponsor:
Information provided by:
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00223769
First received: September 13, 2005
Last updated: February 12, 2008
Last verified: May 2006
  Purpose

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.


Condition Intervention
Spinal Cord Injury
Drug: Oxandrolone

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: The Use of Oxandrolone to Improve Function in Persons With Chronic Spinal Cord Injury

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

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

Estimated Enrollment: 40
Study Start Date: January 2004
Study Completion Date: May 2006
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

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00223769

Locations
United States, Florida
Miami Veterans Affairs Medical Center
Miami, Florida, United States, 33125
Sponsors and Collaborators
Investigators
Principal Investigator: Kresimir Banovac, PhD MD VA Spinal Cord Injury Service
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00223769     History of Changes
Other Study ID Numbers: B2656C
Study First Received: September 13, 2005
Last Updated: February 12, 2008
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
oxandrolone
oxandrin
lean body mass
functional recovery
resistance training

Additional relevant MeSH terms:
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Oxandrolone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Anabolic Agents

ClinicalTrials.gov processed this record on September 18, 2014