title: Androgen Treatment Effects on Motor Function, Cognition, and Behavior in Boys with Klinefelter Syndrome.
abstract: To examine the effects of early low-dose androgen on motor, cognitive, and behavioral function in prepubertal boys with Klinefelter syndrome (47,XXY).
  
  
  
  Double-blind trial of 84 boys, ages 4-12 years, randomized to oxandrolone (Ox; 0.06?mg/kg daily; n?=?43) or placebo (Pl; n?=?41) for 24 months. Standardized assessments were performed at baseline and every 12 months for 24 months evaluating motor, cognitive, and behavioral function.
  
  
  
  The 24-month outcomes were better in the Ox vs. Pl group on 1 of 5 primary endpoints (motor function/strength): Bruininks Visual-Motor scale (P?=?.005), without significant differences between the 2 groups for the other 4 components. Secondary analyses suggested improvement in the Ox vs. Pl group in the anxiety/depression (P?=?.03) and social problems (P?=?.01) scales on the Child Behavior Checklist, anxiety (P?=?.04) on the Piers Harris Self Concept Scale, and interpersonal problems (P?=?.02) on the Children's Depression Inventory, without significant differences in hyperactive or aggressive behaviors.
  
  
  
  This double-blind, randomized trial demonstrates that 24 months of childhood low-dose androgen treatment in boys with Klinefelter syndrome benefited 1 of 5 primary endpoints (visual-motor function). Secondary analyses demonstrated positive effects of androgen on aspects of psychosocial function (anxiety, depression, social problems), without significant effects on cognitive function, or hyperactive or aggressive behaviors.
  
  
  
  ClinicalTrials.gov: NCT00348946.
authors.affiliation: Thomas Jefferson University, Department of Pediatrics, Philadelphia, PA; A.I. DuPont Hospital for Children, Wilmington, DE. Electronic address: judith.ross@jefferson.edu.
authors.forename: Judith L
authors.initials: JL
authors.lastname: Ross
authors.affiliation: Biomedical Research Institute, Philadelphia, PA.
authors.forename: Harvey
authors.initials: H
authors.lastname: Kushner
authors.affiliation: Thomas Jefferson University, Department of Pediatrics, Philadelphia, PA; A.I. DuPont Hospital for Children, Wilmington, DE.
authors.forename: Karen
authors.initials: K
authors.lastname: Kowal
authors.affiliation: Thomas Jefferson University, Department of Pediatrics, Philadelphia, PA; A.I. DuPont Hospital for Children, Wilmington, DE.
authors.forename: Martha
authors.initials: M
authors.lastname: Bardsley
authors.affiliation: Department of Pediatrics, University of Colorado School of Medicine, Aurora, CO.
authors.forename: Shanlee
authors.initials: S
authors.lastname: Davis
authors.affiliation: Department of Psychiatry, Stanford University, Palo Alto, CA.
authors.forename: Allan L
authors.initials: AL
authors.lastname: Reiss
authors.affiliation: Department of Pediatrics, University of Colorado School of Medicine, Aurora, CO.
authors.forename: Nicole
authors.initials: N
authors.lastname: Tartaglia
authors.affiliation: Shore Physicians Group, Somers Point, NJ.
authors.forename: David
authors.initials: D
authors.lastname: Roeltgen
mesh_terms: D000728:Androgens / Q000627:therapeutic use*; D001007:Anxiety / Q000188:drug therapy; D002648:Child; D002652:Child Behavior; D002675:Child, Preschool; D003071:Cognition; D003863:Depression / Q000188:drug therapy; D004311:Double-Blind Method; D006801:Humans; D007398:Interpersonal Relations; D007713:Klinefelter Syndrome / Q000188:drug therapy* / Q000523:psychology; D008297:Male; D053580:Muscle Strength; D009483:Neuropsychological Tests; D010074:Oxandrolone / Q000627:therapeutic use*
chemical_list: D000728:Androgens; D010074:Oxandrolone
keywords: 47,XXY Child; Klinefelter syndrome; United States; androgen; gonadal failure; longitudinal studies; randomized controlled trial; sex chromosome aneuploidy; sex chromosome disorders; sex chromosome variations; testicular function