title: The effect of oxandrolone on the healing of chronic pressure ulcers in persons with spinal cord injury: a randomized trial.
abstract: BACKGROUND
  Anabolic steroids have been reported to improve wound healing.
  
  
  OBJECTIVE
  To determine whether oxandrolone increases the percentage of target pressure ulcers (TPUs) that heal compared with placebo and whether healed ulcers remain closed 8 weeks after treatment.
  
  
  METHODS
  Parallel-group, placebo-controlled, randomized trial conducted from 1 August 2005 to 30 November 2008. Patients, clinical care providers, study personnel, and statisticians were blinded to treatment assignment. (ClinicalTrials.gov: NCT00101361).
  
  
  METHODS
  16 inpatient spinal cord injury (SCI) services at Veterans Affairs medical centers.
  
  
  METHODS
  1900 prescreened, 779 screened, and 212 randomly assigned inpatients with SCI and stage III or IV TPUs.
  
  
  METHODS
  Oxandrolone, 20 mg/d (n = 108), or placebo (n = 104) until the TPU healed or 24 weeks.
  
  
  METHODS
  The primary outcome was healed TPUs. The secondary outcome was the percentage of TPUs that remained healed at 8-week follow-up.
  
  
  RESULTS
  24.1% (95% CI, 16.0% to 32.1%) of TPUs in oxandrolone recipients and 29.8% (CI, 21.0% to 38.6%) in placebo recipients healed (difference, -5.7 percentage points [CI, -17.5 to 6.8 percentage points]; P = 0.40). At 8-week follow-up, 16.7% (CI, 9.6% to 23.7%) of oxandrolone recipients and 15.4% (CI, 8.5% to 22.3%) of placebo recipients retained a healed TPU (difference, 1.3 percentage points [CI, -8.8 to 11.2 percentage points]; P = 0.70). No serious adverse events were related to oxandrolone. Liver enzyme levels were elevated in 32.4% (CI, 23.6% to 41.2%) of oxandrolone recipients and 2.9% (CI, 0.0% to 6.1%) of placebo recipients (P < 0.001).
  
  
  CONCLUSIONS
  Selection of severe wounds may have reduced treatment response. Approximately one third of patients did not complete the study in the treatment and placebo groups. The study was terminated after a futility analysis showed a low probability of detecting a significant difference between the groups.
  
  
  CONCLUSIONS
  Oxandrolone showed no benefit over placebo for improving healing or the percentage of TPUs that remained closed after 8 weeks of treatment.
  
  
  BACKGROUND
  U.S. Department of Veterans Affairs.
authors.affiliation: National Center of Excellence for the Medical Consequences of Spinal Cord Injury, Medical, Spinal Cord Injury and Research Services, James J. Peters Veterans Affairs Medical Center, Bronx, NY 10468, USA. william.bauman@va.gov
authors.forename: William A
authors.initials: WA
authors.lastname: Bauman
authors.forename: Ann M
authors.initials: AM
authors.lastname: Spungen
authors.forename: Joseph F
authors.initials: JF
authors.lastname: Collins
authors.forename: Dennis W
authors.initials: DW
authors.lastname: Raisch
authors.forename: Chester
authors.initials: C
authors.lastname: Ho
authors.forename: George A
authors.initials: GA
authors.lastname: Deitrick
authors.forename: Bernard A
authors.initials: BA
authors.lastname: Nemchausky
authors.forename: Lance L
authors.initials: LL
authors.lastname: Goetz
authors.forename: Jai S
authors.initials: JS
authors.lastname: Park
authors.forename: Michael
authors.initials: M
authors.lastname: Schwartz
authors.forename: John L
authors.initials: JL
authors.lastname: Merritt
authors.forename: Vidya
authors.initials: V
authors.lastname: Jayawardena
authors.forename: Paul
authors.initials: P
authors.lastname: Sandford
authors.forename: Sunil
authors.initials: S
authors.lastname: Sabharwal
authors.forename: Sally A
authors.initials: SA
authors.lastname: Holmes
authors.forename: Fahima
authors.initials: F
authors.lastname: Nasar
authors.forename: Roy
authors.initials: R
authors.lastname: Sasaki
authors.forename: Vandana
authors.initials: V
authors.lastname: Punj
authors.forename: Karin F
authors.initials: KF
authors.lastname: Zachow
authors.forename: Walter C
authors.initials: WC
authors.lastname: Chua
authors.forename: MaryKutty D
authors.initials: MD
authors.lastname: Thomas
authors.forename: Rose C
authors.initials: RC
authors.lastname: Trincher
mesh_terms: D000368:Aged; D045930:Anabolic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008099:Liver / Q000201:enzymology; D008297:Male; D008875:Middle Aged; D010074:Oxandrolone / Q000009:adverse effects / Q000627:therapeutic use*; D011228:Prealbumin / Q000378:metabolism; D003668:Pressure Ulcer / Q000150:complications / Q000188:drug therapy*; D013119:Spinal Cord Injuries / Q000150:complications*; D016896:Treatment Outcome; D014945:Wound Healing / Q000187:drug effects*
chemical_list: D045930:Anabolic Agents; D011228:Prealbumin; D010074:Oxandrolone