Five-year outcomes after oxandrolone administration in severely burned children: a randomized clinical trial of safety and efficacy
Open accessAbstract
BACKGROUND: Oxandrolone, an anabolic agent, has been administered for 1 year post burn with beneficial effects in pediatric patients. However, the long-lasting effects of this treatment have not been studied. This single-center prospective trial determined the long-term effects of 1 year of oxandrolone administration in severely burned children; assessments were continued for up to 4 years post therapy. STUDY DESIGN: Patients 0 to 18 years old with burns covering >30% of the total body surface area were randomized to receive placebo (n = 152) or oxandrolone, 0.1 mg/kg twice daily for 12 months (n = 70). At hospital discharge, patients were randomized to a 12-week exercise program or to standard of care. Resting energy expenditure, standing height, weight, lean body mass, muscle strength, bone mineral content (BMC), cardiac work, rate pressure product, sexual maturation, and concentrations of serum inflammatory cytokines, hormones, and liver enzymes were monitored. RESULTS: Oxandrolone substantially decreased resting energy expenditure and rate pressure product, increased insulin-like growth factor-1 secretion during the first year after burn injury, and, in combination with exercise, increased lean body mass and muscle strength considerably. Oxandrolone-treated children exhibited improved height percentile and BMC content compared with controls. The maximal effect of oxandrolone was found in children aged 7 to 18 years. No deleterious side effects were attributed to long-term administration. CONCLUSIONS: Administration of oxandrolone improves long-term recovery of severely burned children in height, BMC, cardiac work, and muscle strength; the increase in BMC is likely to occur by means of insulin-like growth factor-1. These benefits persist for up to 5 years post burn.
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Oxandrolone has been used to treat muscle loss in HIV and other catabolic disorders, with notable improvements in muscle function and faster recovery.
“Oxandrolone is an anabolic steroid treatment that has been used to treat muscle loss in diseases such as HIV, and also in patients with other catabolic disorders such as neuromuscular diseases, or in individuals who have had severe trauma, burn injury, or infections, with notable improvements in muscle function and faster recovery.120”
From Age-related and disease-related muscle loss: The effect of diabetes, obesity, and other diseases (2014) · cites this paper as [120]
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Age-related and disease-related muscle loss: The effect of diabetes, obesity, and other diseases
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- Authors
- Porro, L. J., Herndon, D. N., Rodriguez, N. A., Jennings, K., Klein, G. L., Mlcak, R. P., Meyer, W. J., Lee, J. O., Suman, O. E., & Finnerty, C. C.
- Affiliations
- Shriners Hospitals for Children - Galveston (US)
- The University of Texas Medical Branch at Galveston (US)
- Corresponding author
- Herndon, David N.
- ORCID
- Venue
- Journal of the American College of Surgeons
- Published
- 2012-04
- Volume
- 214
- Issue
- 4
- Pages
- 489-502
- ISSN
- 1072-7515 (ISSN-L)
- PMC
- PMC3412530
- OpenAlex
- W2064393638
- Cited by
- 143
- References
- 51
- Citations by year
- 2026: 7 · 2025: 11 · 2024: 8 · 2023: 6 · 2022: 11 · 2021: 6 · 2020: 10 · 2019: 10 · 2018: 14 · 2017: 11 · 2016: 15 · 2015: 11 · 2014: 9 · 2013: 10 · 2012: 4
- FWCI
- 8.11
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- Journal of the American College of Surgeons (publishedVersion)
- PubMed (publishedVersion)
- Europe PMC (PubMed Central) (acceptedVersion)
- PubMed Central (acceptedVersion)
- Funders
- National Institutes of Health (UL1TR000071)
- U.S. Public Health Service (H133A070026, H133A70019)
- National Institute of General Medical Sciences (P50GM060338, R01-GM56687-11S1, R01GM056687, T32-GM8256, P50 GM-60338, T32GM008256)
- National Center for Research Resources (KL2RR029875, UL1RR029876)
- National Center for Advancing Translational Sciences
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (R01HD049471)
- Topics
- Health Sciences › Medicine › Epidemiology › Burn Injury Management and Outcomes
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Hormonal and reproductive studies
- Health Sciences › Medicine › Dermatology › Dermatologic Treatments and Research
- Keywords
- oxandrolone, pediatric burns, severe burns, long-term outcomes, anabolic therapy, resting energy expenditure, bone mineral content, lean body mass, muscle strength, insulin-like growth factor I, cardiac work, exercise therapy, inflammatory cytokines, liver enzymes, sexual maturation
- MeSH terms
- Adolescent, Burns, Calorimetry, Indirect, Child, Child, Preschool, Combined Modality Therapy, Energy Metabolism, Exercise Therapy, Female, Follow-Up Studies, Heart, Humans, Insulin-Like Growth Factor I, Liver, Male, Oxandrolone, Prospective Studies, Biomarkers, Bone Density, Treatment Outcome, Anabolic Agents, Body Size, Muscle Strength
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