Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxandrolone | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Part-A
Part-B:
Exclusion Criteria:
Active medical problems including:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kresimir Banovac, PhD MD | VA Spinal Cord Injury Service | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Miami Veterans Affairs Medical Center | Miami | Florida | 33125 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8078451 | Background | Barton RG. Nutrition support in critical illness. Nutr Clin Pract. 1994 Aug;9(4):127-39. doi: 10.1177/0115426594009004127. | |
| 1738212 | Background | 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. |
| Label | URL |
|---|---|
| Center of Excellence in Functional Recovery in Chronic Spinal Cord Injury | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
Not provided
Not provided
| ID | Term |
|---|---|
| D010074 | Oxandrolone |
| ID | Term |
|---|---|
| D000732 | Androstanols |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 2187867 | Background | 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. |
| 3977567 | Background | Cardus D, McTaggart WG. Body sodium and potassium in men with spinal cord injury. Arch Phys Med Rehabil. 1985 Mar;66(3):156-9. |
| 11323537 | Background | 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. |
| 11926325 | Background | 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. |
| D014947 | Wounds and Injuries |
| D011083 |
| Polycyclic Compounds |