Study of Denosumab vs. Zoledronic Acid to Treat Bone Metastases in Men With Hormone-refractory Prostate Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00321620
First received: May 2, 2006
Last updated: February 4, 2014
Last verified: February 2014

May 2, 2006
February 4, 2014
April 2006
October 2009   (final data collection date for primary outcome measure)
Time to the First On-Study SRE (Non-inferiority) [ Time Frame: Up to 40.5 months ] [ Designated as safety issue: No ]
Time to the first on-study skeletal-related event (SRE) analyzed for non-inferiority. Kaplan-Meier estimates of the median and its dispersion are reported.
Not Provided
Complete list of historical versions of study NCT00321620 on ClinicalTrials.gov Archive Site
  • Time to the First On-Study SRE (Superiority) [ Time Frame: Up to 40.5 months ] [ Designated as safety issue: No ]
    Time to the first on-study skeletal-related event (SRE), analyzed for superiority of denosumab. Kaplan-Meier estimates of the median and its dispersion are reported.
  • Time to the First-And-Subsequent On-Study SRE [ Time Frame: Up to 40.5 months ] [ Designated as safety issue: No ]

    Time to the first-and-subsequent on-study skeletal-related event (SRE), analyzed for superiority of denosumab using multiple event analysis, the event must occur at least 21 days after the previous SRE.

    This outcome measure utilizes multiple event times, was analyzed based on a proportional mean model, and is therefore more appropriately summarized by the cumulative mean number of events.

Not Provided
Not Provided
Not Provided
 
Study of Denosumab vs. Zoledronic Acid to Treat Bone Metastases in Men With Hormone-refractory Prostate Cancer
A Randomized, Double-Blind, Multicenter Study of Denosumab Compared With Zoledronic Acid (Zometa®) in the Treatment of Bone Metastases in Men With Hormone-Refractory Prostate Cancer

The purpose of this study is to determine if denosumab is non-inferior to zoledronic acid (Zometa®) in the treatment of bone metastases in men with hormone-refractory prostate cancer

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Bone Metastases
  • Drug: zoledronic acid
    Q4W 4 mg zoledronic acid IV over minimum 15 minutes and 120 mg denosumab placebo SC
    Other Name: Zometa
  • Biological: denosumab
    Q4W 120 mg denosumab SC and 4 mg zoledronic acid placebo IV over a minimum of 15 minutes
  • Active Comparator: zoledronic acid
    Intervention: Drug: zoledronic acid
  • Experimental: denosumab
    Intervention: Biological: denosumab

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1904
February 2012
October 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Men >/= 18 years of age with histologically confirmed prostate cancer
  • Radiographic evidence of at least one bone metastasis
  • Failure of at least one hormonal therapy as evidenced by a rising PSA
  • Serum testosterone level of <50 ng/dL
  • ECOG PS 0, 1, or 2
  • Adequate organ function

Exclusion Criteria:

  • Current or prior IV bisphosphonate administration
  • Current or prior oral bisphosphonates for bone mets
  • Life expectancy of less than 6 months
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00321620
20050103
Yes
Amgen
Amgen
Not Provided
Study Director: MD Amgen
Amgen
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP