| Five-year outcomes after oxandrolone administration in severely burned children: a randomized clinical trial of safety and efficacy. | |
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MedLine Citation:
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PMID: 22463890 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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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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Authors:
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Laura J Porro; David N Herndon; Noe A Rodriguez; Kristofer Jennings; Gordon L Klein; Ronald P Mlcak; Walter J Meyer; Jong O Lee; Oscar E Suman; Celeste C Finnerty |
Publication Detail:
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Type: Journal Article; Randomized Controlled Trial; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't |
Journal Detail:
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Title: Journal of the American College of Surgeons Volume: 214 ISSN: 1879-1190 ISO Abbreviation: J. Am. Coll. Surg. Publication Date: 2012 Apr |
Date Detail:
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Created Date: 2012-04-02 Completed Date: 2012-07-27 Revised Date: 2013-04-03 |
Medline Journal Info:
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Nlm Unique ID: 9431305 Medline TA: J Am Coll Surg Country: United States |
Other Details:
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Languages: eng Pagination: 489-502; discussion 502-4 Citation Subset: AIM; IM |
Copyright Information:
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Copyright © 2012 American College of Surgeons. Published by Elsevier Inc. All rights reserved. |
Affiliation:
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Shriners Hospitals for Children-Galveston, Galveston, TX 77550, USA. |
| Data Bank Information | |
Bank Name/Acc. No.:
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ClinicalTrials.gov/NCT00675714 |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Adolescent Anabolic Agents / pharmacology, therapeutic use* Biological Markers / metabolism Body Size / drug effects Bone Density / drug effects Burns / drug therapy*, metabolism, rehabilitation Calorimetry, Indirect Child Child, Preschool Combined Modality Therapy Energy Metabolism / drug effects Exercise Therapy Female Follow-Up Studies Heart / drug effects Humans Insulin-Like Growth Factor I / metabolism Liver / drug effects Male Muscle Strength / drug effects Oxandrolone / pharmacology, therapeutic use* Prospective Studies Treatment Outcome |
| Grant Support | |
ID/Acronym/Agency:
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H133A070026//PHS HHS; H133A70019//PHS HHS; KL2 RR029875/RR/NCRR NIH HHS; KL2RR029875/RR/NCRR NIH HHS; P50 GM060338/GM/NIGMS NIH HHS; P50-GM60338/GM/NIGMS NIH HHS; R01 GM056687/GM/NIGMS NIH HHS; R01 HD049471/HD/NICHD NIH HHS; R01-GM56687-11S1/GM/NIGMS NIH HHS; R01-HD049471/HD/NICHD NIH HHS; T32 GM008256/GM/NIGMS NIH HHS; T32-GM8256/GM/NIGMS NIH HHS; UL1 RR029876/RR/NCRR NIH HHS; UL1 TR000071/TR/NCATS NIH HHS; UL1RR029876/RR/NCRR NIH HHS |
| Chemical | |
Reg. No./Substance:
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0/Anabolic Agents; 0/Biological Markers; 53-39-4/Oxandrolone; 67763-96-6/Insulin-Like Growth Factor I |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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