BACKGROUND: Severe burns cause exaggerated catabolism of muscle protein and inhibit bone deposition. Weakness and bony growth arrest interfere with rehabilitation. The purpose of this study was to determine whether oxandrolone administration for 1 year after the burn reverses muscle and bone catabolism in hypermetabolic pediatric burn patients. METHODS:Children with burns greater than 40% total body surface area were enrolled into a randomized controlled trial to receive oxandrolone as a long-term anabolic agent. All patients received similar clinical care. Subjects were studied at discharge (95% healed) and at 6, 9, and 12 months after the burn, after treatment with 0.1 mg/kg po bid or placebo. Serum hepatic transaminases were measured. Lean body mass (LBM), bone mineral content (BMC,) and bone mineral density (BMD) were measured by dual energy x-ray absorptiometry. Patients completed a safety questionnaire and were reviewed clinically at intervals. RESULTS: The groups were similar in age, weight, and total body surface area burned. LBM was significantly greater with oxandrolone at 6, 9, and 12 months after the burn (P < .001) and BMC at 12 months (P < .016). Age- and gender-matched BMD z scores were significantly better with oxandrolone (P < .039). Liver transaminases were unaffected. CONCLUSIONS: Long-term administration of oxandrolone safely improves LBM, BMC, and BMD in severely burned children. Copyright 2004 Elsevier Inc.
RCT Entities:
BACKGROUND: Severe burns cause exaggerated catabolism of muscle protein and inhibit bone deposition. Weakness and bony growth arrest interfere with rehabilitation. The purpose of this study was to determine whether oxandrolone administration for 1 year after the burn reverses muscle and bone catabolism in hypermetabolic pediatric burn patients. METHODS:Children with burns greater than 40% total body surface area were enrolled into a randomized controlled trial to receive oxandrolone as a long-term anabolic agent. All patients received similar clinical care. Subjects were studied at discharge (95% healed) and at 6, 9, and 12 months after the burn, after treatment with 0.1 mg/kg po bid or placebo. Serum hepatic transaminases were measured. Lean body mass (LBM), bone mineral content (BMC,) and bone mineral density (BMD) were measured by dual energy x-ray absorptiometry. Patients completed a safety questionnaire and were reviewed clinically at intervals. RESULTS: The groups were similar in age, weight, and total body surface area burned. LBM was significantly greater with oxandrolone at 6, 9, and 12 months after the burn (P < .001) and BMC at 12 months (P < .016). Age- and gender-matched BMD z scores were significantly better with oxandrolone (P < .039). Liver transaminases were unaffected. CONCLUSIONS: Long-term administration of oxandrolone safely improves LBM, BMC, and BMD in severely burned children. Copyright 2004 Elsevier Inc.
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