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. (June 2013)

• Record Type: Journal Article
• Authors: Bouloux, Pierre M. G.; Legros, Jean-Jacques; Elbers, Jolanda M. H.; Geurts, T. B. Paul; Kaspers, Marion J. G. H.; Meehan, Alan G.; Meuleman, Eric J. H.
• Is Part Of: Aging male. Volume 16:Number 2(2013:Jun.)
• Page Start: 38
• Page End: 47
• Publication Date: 2013-06
• Subjects: Aging -- Periodicals; Men -- Periodicals; Gerontology -- Periodicals; Men -- Health and hygiene -- Periodicals; Aging -- periodicals; Geriatric -- periodicals; Men -- periodicals; Aged -- periodicals; Aged, 80 and over -- periodicals; 612.67
• DOI: 10.3109/13685538.2013.773420
• Languages: English
• ISSNs: 1368-5538

Abstract

<abstract> <title>Abstract</title> <p> <italic>Objective</italic>: 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).</p> <p> <italic>Methods</italic>: Three hundred twenty-two men ≥50 years with TD symptoms and calculated free testosterone &lt;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.</p> <p> <italic>Results</italic>: 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.</p> <p> <italic>Conclusions</italic>: Treatment with oral TU led to improvement in BMD, LBM and BFM in aging men with symptomatic TD.</p> </abstract>