NCT00223769

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2004

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
Last Updated

February 13, 2008

Status Verified

May 1, 2006

First QC Date

September 13, 2005

Last Update Submit

February 12, 2008

Conditions

Spinal Cord Injury

Keywords

oxandroloneoxandrinlean body massfunctional recoveryresistance training

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (3)

  • 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

Interventions

OxandroloneDRUG

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Miami Veterans Affairs Medical Center

Miami, Florida, 33125, United States

Location

Related Publications (6)

  • Barton RG. Nutrition support in critical illness. Nutr Clin Pract. 1994 Aug;9(4):127-39. doi: 10.1177/0115426594009004127.

    PMID: 8078451BACKGROUND

  • 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.

    PMID: 1738212BACKGROUND

  • 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.

    PMID: 2187867BACKGROUND

  • Cardus D, McTaggart WG. Body sodium and potassium in men with spinal cord injury. Arch Phys Med Rehabil. 1985 Mar;66(3):156-9.

    PMID: 3977567BACKGROUND

  • 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.

    PMID: 11323537BACKGROUND

  • 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.

    PMID: 11926325BACKGROUND

Related Links

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Oxandrolone

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Intervention Hierarchy (Ancestors)

AndrostanolsAndrostanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Kresimir Banovac, PhD MD

    VA Spinal Cord Injury Service

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
FED

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 22, 2005

Study Start

January 1, 2004

Study Completion

May 1, 2006

Last Updated

February 13, 2008

Record last verified: 2006-05

Locations

US(1)