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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00321620
Recruitment Status : Completed
First Posted : May 4, 2006
Results First Posted : March 21, 2014
Last Update Posted : August 29, 2018
Sponsor:
Information provided by (Responsible Party):
Amgen

Tracking Information
First Submitted Date  ICMJE May 2, 2006
First Posted Date  ICMJE May 4, 2006
Results First Submitted Date  ICMJE December 10, 2010
Results First Posted Date  ICMJE March 21, 2014
Last Update Posted Date August 29, 2018
Actual Study Start Date  ICMJE April 1, 2006
Actual Primary Completion Date October 1, 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 4, 2014)
Time to the First On-Study SRE (Non-inferiority) [ Time Frame: Up to 40.5 months ]
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.
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00321620 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 4, 2014)
  • Time to the First On-Study SRE (Superiority) [ Time Frame: Up to 40.5 months ]
    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 ]
    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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Denosumab vs. Zoledronic Acid to Treat Bone Metastases in Men With Hormone-refractory Prostate Cancer
Official Title  ICMJE 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
Brief Summary 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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE Bone Metastases
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Active Comparator: zoledronic acid
    Intervention: Drug: zoledronic acid
  • Experimental: denosumab
    Intervention: Biological: denosumab
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 16, 2009)
1904
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE February 24, 2012
Actual Primary Completion Date October 1, 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Argentina,   Australia,   Austria,   Belgium,   Brazil,   Bulgaria,   Canada,   Chile,   Costa Rica,   Czech Republic,   Denmark,   Estonia,   Finland,   France,   Germany,   Greece,   Hungary,   India,   Israel,   Italy,   Latvia,   Lithuania,   Mexico,   Netherlands,   New Zealand,   Panama,   Peru,   Poland,   Romania,   Russian Federation,   Slovakia,   South Africa,   Spain,   Sweden,   Switzerland,   Turkey,   Ukraine,   United Kingdom,   United States
 
Administrative Information
NCT Number  ICMJE NCT00321620
Other Study ID Numbers  ICMJE 20050103
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Amgen
Study Sponsor  ICMJE Amgen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: MD Amgen
PRS Account Amgen
Verification Date August 2018

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