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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2006-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Spinal Cord Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Oxandrolone

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No