Five-year outcomes after oxandrolone administration in severely burned children

A randomized clinical trial of safety and efficacy

Laura J. Porro, David Herndon, Noe A. Rodriguez, Kristofer Jennings, Gordon L. Klein, Ronald P. Mlcak, Walter Meyer, Jong Lee, Oscar Suman, Celeste Finnerty

Research output: Contribution to journalArticle

61 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)489-502
Number of pages14
JournalJournal of the American College of Surgeons
Volume214
Issue number4
DOIs
StatePublished - Apr 2012

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Oxandrolone
Randomized Controlled Trials
Safety
Bone Density
Muscle Strength
Somatomedins
Energy Metabolism
Exercise
Anabolic Agents
Pressure
Sexual Maturation
Body Surface Area
Standard of Care
Burns
Myocardium
Placebos
Body Weight
Hormones
Pediatrics
Cytokines

Keywords

  • BMC
  • BMD
  • bone mineral content
  • bone mineral density
  • cardiac output
  • CO
  • heart rate
  • HR
  • IGF-1
  • IGFBP
  • IL
  • insulin-like growth factor-1
  • insulin-like growth factor-binding protein
  • interleukin
  • rate pressure product
  • REE
  • resting energy expenditure
  • RPP
  • TBSA
  • total body surface area

ASJC Scopus subject areas

  • Surgery

Cite this

Five-year outcomes after oxandrolone administration in severely burned children : A randomized clinical trial of safety and efficacy. / Porro, Laura J.; Herndon, David; Rodriguez, Noe A.; Jennings, Kristofer; Klein, Gordon L.; Mlcak, Ronald P.; Meyer, Walter; Lee, Jong; Suman, Oscar; Finnerty, Celeste.

In: Journal of the American College of Surgeons, Vol. 214, No. 4, 04.2012, p. 489-502.

Research output: Contribution to journalArticle

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abstract = "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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T2 - A randomized clinical trial of safety and efficacy

AU - Porro, Laura J.

AU - Herndon, David

AU - Rodriguez, Noe A.

AU - Jennings, Kristofer

AU - Klein, Gordon L.

AU - Mlcak, Ronald P.

AU - Meyer, Walter

AU - Lee, Jong

AU - Suman, Oscar

AU - Finnerty, Celeste

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AB - 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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KW - rate pressure product

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KW - resting energy expenditure

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KW - total body surface area

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