The Journal of Urology
Volume 182, Issue 6 , Pages 2670-2676 , December 2009

Effects of Denosumab on Bone Mineral Density in Men Receiving Androgen Deprivation Therapy for Prostate Cancer

  • Matthew R. Smith

      Affiliations

    • Massachusetts General Hospital Cancer Center, Boston, Massachusetts
    • Corresponding Author InformationCorrespondence: Massachusetts General Hospital Cancer Center, Yawkey 7038, 55 Fruit St., Boston, Massachusetts 02114 (telephone: 617-724-5257; FAX: 617-726-4899)
    • Supported by a National Institutes of Health K24 Midcareer Investigator Award (5K24CA121990-02) and grants from the Prostate Cancer Foundation.
    • Financial interest and/or other relationship with Amgen, GTx and Novartis.
  • ,
  • Fred Saad

      Affiliations

    • Centre Hospitalier de l'Université de Montréal, Montréal, Quebec, Canada
    • Financial interest and/or other relationship with Amgen and Novartis.
  • ,
  • Blair Egerdie

      Affiliations

    • Urology Associates Urologic Medical Research, Kitchener, Ontario, Canada
    • Financial interest and/or other relationship with Amgen, Astellas, Bayer HealthCare, GlaxoSmithKline and Pfizer.
  • ,
  • Maciej Szwedowski

      Affiliations

    • Wojewódzkie Centrum Medyczne, Opole, Poland
    • Financial interest and/or other relationship with Amgen.
  • ,
  • Teuvo L.J. Tammela

      Affiliations

    • Tampere University Hospital, Tampere, Finland
    • Financial interest and/or other relationship with Amgen, Orion Pharma and Ferring.
  • ,
  • Chunlei Ke

      Affiliations

    • Amgen Inc., Thousand Oaks, California
    • Financial interest and/or other relationship with Amgen.
  • ,
  • Benjamin Z. Leder

      Affiliations

    • Endocrine Unit, Boston, Massachusetts
    • Financial interest and/or other relationship with Amgen and Novartis.
  • ,
  • Carsten Goessl

      Affiliations

    • Amgen Inc., Thousand Oaks, California
    • Financial interest and/or other relationship with Amgen.

Received 21 April 2009

  • Image Result

    Forest plots of treatment effect of denosumab at 36 months in percentage change from baseline (±95% CI) in BMD at the lumbar spine. Results are presented as least squares means. Vertical bar represent

    Forest plots of treatment effect of denosumab at 36 months in percentage change from baseline (±95% CI) in BMD at the lumbar spine. Results are presented as least squares means. Vertical bar represents 95% CI for percentage difference in lumbar spine BMD between denosumab and placebo for overall population at 36 months. Asterisk indicates p <0.0001 vs placebo. a indicates p <0.05 between subgroups. b indicates p <0.0001 between subgroups. NS, not significant between subgroups.

  • Image Result
    Forest plots of treatment effect of denosumab at 36 months in percentage change from baseline (±95% CI) in BMD at total hip. Results are presented as least squares means. Vertical bar represents 95% C

    Forest plots of treatment effect of denosumab at 36 months in percentage change from baseline (±95% CI) in BMD at total hip. Results are presented as least squares means. Vertical bar represents 95% CI for percentage difference in total hip BMD between denosumab and placebo for overall population at 36 months. Asterisk indicates p <0.0001 vs placebo. a indicates p <0.05 between subgroups. b indicates p <0.0001 between subgroups. NS, not significant between subgroups.

  • Image Result
    Forest plots of treatment effect of denosumab at 36 months in percentage change from baseline (±95% CI) in BMD at distal 1/3 radius. Results are presented as least squares means. Vertical bar represen

    Forest plots of treatment effect of denosumab at 36 months in percentage change from baseline (±95% CI) in BMD at distal 1/3 radius. Results are presented as least squares means. Vertical bar represents 95% CI for percentage difference in distal 1/3 radius BMD between denosumab and placebo for overall population at 36 months. Asterisk indicates p <0.0001 vs placebo. Dagger indicates p ≤0.01 vs placebo. a indicates p <0.05 between subgroups. NS, not significant between subgroups.

 Study received institutional review board approval.

 Supported by Amgen Inc., Thousand Oaks, California.

 Clinical Trial Registration NCT00089674 (www.clinicaltrials.gov).

 See Editorial on page 2557.

PII: S0022-5347(09)02070-9

doi: 10.1016/j.juro.2009.08.048

The Journal of Urology
Volume 182, Issue 6 , Pages 2670-2676 , December 2009