The Journal of Urology
Volume 182, Issue 2 , Pages 509-516 , August 2009

Denosumab Treatment of Prostate Cancer With Bone Metastases and Increased Urine N-Telopeptide Levels After Therapy With Intravenous Bisphosphonates: Results of a Randomized Phase II Trial

  • Karim Fizazi

      Affiliations

    • Institut Gustave Roussy and University of Paris XI, Villejuif, France
    • Corresponding Author InformationCorrespondence: Department of Medicine, Institut Gustave Roussy and University of Paris XI, 39 Rue Camille Desmoulins, 94800 Villejuif, France (telephone: 33 1 42 11 43 17; FAX: 33 1 42 11 52 11)
    • Financial interest and/or other relationship with Amgen, Novartis, AstraZeneca, Sanofi-Aventis, Ipsen-Beaufour, Pharmion, Bristol Myers Squibb and Takeda.
    • ,
  • Linda Bosserman

      Affiliations

    • Wilshire Oncology Medical Group, La Verne, California
    • Financial interest and/or other relationship with Amgen and Pfizer.
    • ,
  • Guozhi Gao

      Affiliations

    • Amgen Inc., San Francisco, California
    • Financial interest and/or other relationship with Amgen.
    • ,
  • Tomas Skacel

      Affiliations

    • Amgen (Europe) GmbH, Zug, Switzerland
    • Financial interest and/or other relationship with Amgen.
    • ,
  • Richard Markus

      Affiliations

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

Received 22 December 2008

  • Image Result

    Random treatment assignments

    Random treatment assignments

  • Image Result

    Proportion of patients with prostate cancer achieving uNTx less than 50 nM BCE/mM creatinine at 13 and 25 weeks for all patients and stratified by baseline uNTx (A and C), and median (Q1, Q3) percent

    Proportion of patients with prostate cancer achieving uNTx less than 50 nM BCE/mM creatinine at 13 and 25 weeks for all patients and stratified by baseline uNTx (A and C), and median (Q1, Q3) percent change in uNTx/Cr over time (B).

  • Image Result
    Proportion of patients experiencing 1 or more SREs during study.

    Proportion of patients experiencing 1 or more SREs during study.

 Clinical Trial Registration NCT00104650 (www.clinicaltrials.gov).

 Supported by Amgen Inc.

 Study received institutional review board/ethics committee approval.

PII: S0022-5347(09)00932-X

doi: 10.1016/j.juro.2009.04.023

The Journal of Urology
Volume 182, Issue 2 , Pages 509-516 , August 2009

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