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Original Research |

The Effect of Oxandrolone on the Healing of Chronic Pressure Ulcers in Persons With Spinal Cord Injury: A Randomized Trial

William A. Bauman, MD; Ann M. Spungen, EdD; Joseph F. Collins, ScD; Dennis W. Raisch, RPH, PhD; Chester Ho, MD; George A. Deitrick, MD; Bernard A. Nemchausky, MD; Lance L. Goetz, MD; Jai S. Park, MD; Michael Schwartz, MD; John L. Merritt, MD; Vidya Jayawardena, MD; Paul Sandford, MD; Sunil Sabharwal, MD; Sally A. Holmes, MD; Fahima Nasar, MD; Roy Sasaki, MD; Vandana Punj, MD; Karin F. Zachow, MD; Walter C. Chua, MD; MaryKutty D. Thomas, MD; and Rose C. Trincher†, MD
[+] Article and Author Information

† Deceased.


From the 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, New York; The Mount Sinai School of Medicine, New York, New York; Veterans Affairs Cooperative Studies Program Coordinating Center, Perry Point Veterans Affairs Medical Center, Perry Point, Maryland; Veterans Affairs Cooperative Study Program Clinical Research Pharmacy Coordinating Center and College of Pharmacy, University of New Mexico, Albuquerque, New Mexico; Louis Stokes Cleveland Veterans Affairs Medical Center, Cleveland, Ohio; University of Calgary, Calgary, Alberta, Canada; Veterans Affairs North Texas Health Care System, Dallas, Texas; Virginia Commonwealth University, Richmond, Virginia; Spinal Cord Injury Service, St. Louis Veterans Affairs Medical Center, St. Louis, Missouri; James A. Haley Veterans' Hospital and University of South Florida College of Medicine, University of South Florida, Tampa, Florida; Hunter H. McGuire Veterans Affairs Medical Center, Richmond, Virginia; Tufts University School of Medicine, and Harvard Medical School, Boston, Massachusetts; Clement J. Zablocki Veterans Affairs Medical Center and Medical College of Wisconsin, Milwaukee, Wisconsin; Veterans Affairs Boston Healthcare System, West Roxbury, Massachusetts; Michael E. DeBakey Veterans Affairs Medical Center and Baylor College of Medicine, Houston, Texas; Veterans Affairs San Diego Healthcare System, San Diego, California; Veterans Affairs Palo Alto Healthcare System, Palo Alto, California; Stanford School of Medicine, Stanford, California; Spinal Cord Injury Service, Miami Veterans Affairs Healthcare System, Miami, Florida; Veterans Affairs Long Beach Healthcare System, Long Beach, California; Charlie Norwood Veterans Affairs Medical Center and Georgia Health Sciences University, Augusta, Georgia.

Note: Dr. Collins had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Dr. Collins was the statistician responsible for the statistical analysis for this study.

Grant Support: By the Veterans Affairs Clinical Science Research and Development Service, Cooperative Study #535; Rehabilitation Research and Development, National Center of Excellence for the Medical Consequences of Spinal Cord Injury (B2648C, B4162C, and B9212C); and Department of Veterans Affairs, Spinal Cord Injury Services.

Potential Conflicts of Interest: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M12-1537.

Reproducible Research Statement: Study protocol, statistical code, and data set: Available from Dr. Collins (e-mail, joseph.collins2@va.gov).

Requests for Single Reprints: William A. Bauman, MD, Veterans Affairs Rehabilitation Research and Development, National Center of Excellence for the Medical Consequences of Spinal Cord Injury, Suite 7A-13, James J. Peters Veterans Affairs Medical Center, 130 West Kingsbridge Road, Bronx, NY 10468; e-mail, william.bauman@va.gov.

Current Author Addresses: Drs. Bauman and Spungen: Veterans Affairs Rehabilitation Research and Development, National Center of Excellence for the Medical Consequences of Spinal Cord Injury, Suite 7A-13, James J. Peters Veterans Affairs Medical Center, 130 West Kingsbridge Road, Bronx, NY 10468.

Dr. Collins: VA Maryland Health Care System, Cooperative Study Program Coordinating Center, 151E Building, 362T, Boiler House Road, Perry Point, MD 21902.

Dr. Raisch: Veterans Affairs Cooperative Studies Program, Clinical Research Pharmacy 2401 Centre, SE, Albuquerque, NM 87106.

Dr. Ho: Division of Physical Medicine and Rehabilitation, Department of Clinical Neurosciences, Room 1195D, Foothills Hospital, 1403 29th Street NW, Calgary, Alberta T2N 2T9, Canada.

Dr. Deitrick: Spinal Cord Injury Service (128), James J. Peters Veterans Affairs Medical Center, 130 West Kingsbridge Road, Bronx, NY 10468.

Drs. Nemchausky: Spinal Cord Injury Service (128), Room A123, Hines VA Medical Center, 5th Avenue and Roosevelt Road, Hines, IL 60141.

Dr. Goetz: Richmond VA Medical Center, Spinal Cord Injury Service (128), 1201 Broad Rock Boulevard, Richmond, VA 23249.

Dr. Park: Saint Louis VA Medical Center, Spinal Cord Injury Service (128JB), 1 Jefferson Barracks, Saint Louis, MO 63125.

Dr. Schwartz: Edward Hines VA Hospital, 5000 South Fifth Avenue/11INF, Building 1, Room F440, Hines, IL 60141.

Dr. Merritt: James A. Haley VA Hospital, Spinal Cord Injury Service (128), 13000 Bruce B. Downs Boulevard, Tampa, FL 33612.

Drs. Jayawardena and Sabharwal: VA Boston Health Care System (West Roxbury Division), Spinal Cord Injury Service (128), 1400 VFW Parkway, West Roxbury, MA 02132.

Dr. Sandford: Milwaukee VA Medical Center, Spinal Cord Injury Service (128), 5000 West National Avenue, Milwaukee, WI 53295.

Dr. Holmes: Michael E. DeBakey VA Medical Center, Spinal Cord Injury Service (128), 2002 Holcombe Boulevard, Houston, TX 77030.

Dr. Nasar: San Diego VA Medical Center, Spinal Cord Injury Service (128), 3350 La Jolla Village Drive, San Diego, CA 92161.

Drs. Sasaki and Punj: VA Palo Alto Health Care Service, Spinal Cord Injury Service (128), 3801 Miranda Avenue, Palo Alto, CA 94304.

Dr. Zachow: VA Medical Center Miami, Spinal Cord Injury Service (128), 1201 NW 16th Street, Miami, FL 33125.

Dr. Chua: VA Long Beach Health Care Services, Surgeon, SCI/D HCG, 5901 East 7th Street (07/128), Building 150, Long Beach, CA 90822.

Dr. Thomas: Charlie Norwood VA Medical Center, Spinal Cord Injury Service (128), 1 Freedom Way, Augusta, GA 30904.

Author Contributions: Conception and design: W.A. Bauman, A.M. Spungen, J.F. Collins, D.W. Raisch, C. Ho, G.A. Deitrick, B.A. Nemchausky, P. Sandford, S.A. Holmes, R. Sasaki.

Analysis and interpretation of the data: W.A. Bauman, A.M. Spungen, J.F. Collins, D.W. Raisch, J.S. Park, S. Sabharwal, F. Nasar, R. Sasaki.

Drafting of the article: W.A. Bauman, A.M. Spungen, J.F. Collins, S. Sabharwal, R. Sasaki.

Critical revision of the article for important intellectual content: W.A. Bauman, A.M. Spungen, J.F. Collins, D.W. Raisch, L.L. Goetz, J.S. Park, S. Sabharwal, R. Sasaki, K.F. Zachow.

Final approval of the article: W.A. Bauman, J.F. Collins, D.W. Raisch, C. Ho, L.L. Goetz, J.S. Park, M. Schwartz, J.L. Merritt, P. Sandford, S.A. Holmes, R. Sasaki.

Provision of study materials or patients: W.A. Bauman, D.W. Raisch, C. Ho, G.A. Deitrick, B.A. Nemchausky, L.L. Goetz, J.S. Park, M. Schwartz, J.L. Merritt, V. Jayawardena, P. Sandford, S. Sabharwal, S.A. Holmes, R. Sasaki, V. Punj, K.F. Zachow, W.C. Chua, M.D. Thomas, R.C. Trincher.

Statistical expertise: W.A. Bauman, A.M. Spungen, J.F. Collins, R. Sasaki.

Obtaining of funding: W.A. Bauman, A.M. Spungen, R. Sasaki.

Administrative, technical, or logistic support: W.A. Bauman, A.M. Spungen, D.W. Raisch, C. Ho, J.S. Park, P. Sandford, R. Sasaki.

Collection and assembly of data: W.A. Bauman, A.M. Spungen, C. Ho, G.A. Deitrick, J.S. Park, M. Schwartz, J.L. Merritt, V. Jayawardena, P. Sandford, S. Sabharwal, R. Sasaki, V. Punj, K.F. Zachow, W.C. Chua, M.D. Thomas, R.C. Trincher.


Ann Intern Med. 2013;158(10):718-726. doi:10.7326/0003-4819-158-10-201305210-00006
Text Size: A A A

Chinese translation

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.

Design: 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)

Setting: 16 inpatient spinal cord injury (SCI) services at Veterans Affairs medical centers.

Patients: 1900 prescreened, 779 screened, and 212 randomly assigned inpatients with SCI and stage III or IV TPUs.

Intervention: Oxandrolone, 20 mg/d (n = 108), or placebo (n = 104) until the TPU healed or 24 weeks.

Measurements: 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).

Limitations: 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.

Conclusion: Oxandrolone showed no benefit over placebo for improving healing or the percentage of TPUs that remained closed after 8 weeks of treatment.

Primary Funding Source: U.S. Department of Veterans Affairs.

Figures

Grahic Jump Location
Figure 1.

Study flow diagram.

Patients received oxandrolone or placebo until the TPU healed or for 24 wk, whichever occurred first. CHD = coronary heart disease; CHF = congestive heart failure; TPU = target pressure ulcer.

Grahic Jump Location
Grahic Jump Location
Appendix Figure.

VA NSC score, by week of study treatment.

Estimates and 95% CIs are from a linear mixed model with terms for drug, week, and drug-by-week interaction. The VA NSC score did not vary by treatment group during the treatment period (F = 0.02; P = 0.88). The number of patients in the oxandrolone and placebo groups were 108 and 104 at baseline (0 wk), 75 and 71 at 12 wk, and 63 and 63 at 24 wk, respectively. Severity is inversely scored, with 4.0 being the worst and 1.0 being the best. VA NSC = Veterans Affairs Nutrition Status Classification.

Grahic Jump Location
Grahic Jump Location
Figure 2.

Serum prealbumin level, by week of treatment.

Estimates and 95% CIs are from a linear mixed model with terms for drug, week, and drug-by-week interaction. The treatment groups were statistically different for serum prealbumin levels across time (F = 170.3; P < 0.001). The dashed lines represent the upper and lower limits of normal range for serum prealbumin levels.

Grahic Jump Location

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Summary for Patients

Oxandrolone Treatment for Pressure Ulcers

The full report is titled “The Effect of Oxandrolone on the Healing of Chronic Pressure Ulcers in Persons With Spinal Cord Injury. A Randomized Trial.” It is in the 21 May 2013 issue of Annals of Internal Medicine (volume 158, pages 718-726). The authors are W.A. Bauman, A.M. Spungen, J.F. Collins, D.W. Raisch, C. Ho, G.A. Deitrick, B.A. Nemchausky, L.L. Goetz, J.S. Park, M. Schwartz, J.L. Merritt, V. Jayawardena, P. Sandford, S. Sabharwal, S.A. Holmes, F. Nasar, R. Sasaki, V. Punj, K.F. Zachow, W.C. Chua, M.D. Thomas, and R.C. Trincher

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