title: Effects of oral testosterone undecanoate therapy on bone mineral density and body composition in 322 aging men with symptomatic testosterone deficiency: a 1-year, randomized, placebo-controlled, dose-ranging study.
abstract: OBJECTIVE
  We investigated the effects of oral testosterone undecanoate (TU) on bone mineral density (BMD), lean body mass (LBM) and body fat mass (BFM) in aging men with symptomatic testosterone deficiency (TD).
  
  
  METHODS
  Three hundred twenty-two men ≥50 years with TD symptoms and calculated free testosterone <0.26 nmol/L participated in a multicenter, double-blind, placebo-controlled trial. Patients were randomized to placebo, oral TU 80 mg/d, oral TU 160 mg/d, or oral TU 240 mg/d, administered as divided doses with normal meals. BMD of the hip and lumbar spine were evaluated by dual energy X-ray absorptiometry (DEXA), and body composition (LBM and BFM) by whole body DEXA.
  
  
  RESULTS
  Oral TU significantly increased BMD at Month 12 at the lumbar spine (240 mg/d), total hip (240 mg/d), and trochanter and intertrochanter (160 and 240 mg/d) compared with placebo. Oral TU significantly increased LBM at Months 6 and 12 for all oral TU groups compared with placebo. BFM significantly decreased at Month 6 (all oral TU groups) and Month 12 (160 mg/d) compared with placebo. The effects on BMD and body composition showed a clear dose response.
  
  
  CONCLUSIONS
  Treatment with oral TU led to improvement in BMD, LBM and BFM in aging men with symptomatic TD.
authors.affiliation: Centre for Neuroendocrinology, Royal Free and University College School of Medicine, London, UK. p.bouloux@ucl.ac.uk
authors.forename: Pierre M G
authors.initials: PM
authors.lastname: Bouloux
authors.forename: Jean-Jacques
authors.initials: JJ
authors.lastname: Legros
authors.forename: Jolanda M H
authors.initials: JM
authors.lastname: Elbers
authors.forename: T B Paul
authors.initials: TB
authors.lastname: Geurts
authors.forename: Marion J G H
authors.initials: MJ
authors.lastname: Kaspers
authors.forename: Alan G
authors.initials: AG
authors.lastname: Meehan
authors.forename: Eric J H
authors.initials: EJ
authors.lastname: Meuleman
mesh_terms: D015502:Absorptiometry, Photon / Q000379:methods; D000284:Administration, Oral; D000368:Aged; D000369:Aged, 80 and over; D000375:Aging / Q000187:drug effects*; D001823:Body Composition / Q000187:drug effects*; D015519:Bone Density / Q000187:drug effects*; D003677:Deficiency Diseases / Q000188:drug therapy; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D053580:Muscle Strength / Q000187:drug effects; D011446:Prospective Studies; D012016:Reference Values; D018570:Risk Assessment; D013739:Testosterone / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000172:deficiency*; D016896:Treatment Outcome
chemical_list: D013739:Testosterone; C010792:testosterone undecanoate