Skip to main content
OpenTrials
Completed

NCT Number: NCT00223769

The Use of Anabolic Steroids to Improve Function After 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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Miami Veterans Affairs Medical Center

Miami, Florida, 33125, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oxandrolone

Drug

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

Sponsors and collaborators

Lead sponsor

US Department of Veterans Affairs

Fed

Registry information

Official study title

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

Important dates

Study start
2004
Study completion
2006
First posted
Sep 22, 2005
Registry last updated
Feb 13, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.