Double-blind Study of Denosumab Compared With Zoledronic Acid in the Treatment of Bone Metastases in Men With Hormone-refractory Prostate Cancer

The recruitment status of this study is unknown because the information has not been verified recently.

Verified November 2010 by Amgen.
Recruitment status was Active, not recruiting

Sponsor:

Information provided by:

Amgen

ClinicalTrials.gov Identifier:

NCT00321620

First received: May 2, 2006

Last updated: November 24, 2010

Last verified: November 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

May 2, 2006

Last Updated Date

November 24, 2010

Start Date ^ICMJE

April 2006

Primary Completion Date

October 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Time to the first on-study SRE (non-inferiority) [ Time Frame: Onset of event for 745 subjects ] [ Designated as safety issue: No ]

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

Time to the first on-study SRE (superiority) [ Time Frame: Onset of event for 745 subjects ] [ Designated as safety issue: No ]
Time to the first-and-subsequent on-study SRE (superiority, using multiple event analysis) [ Time Frame: Onset of first and subsequent event ] [ Designated as safety issue: No ]
Subject incidence of treatment-emergent adverse events [ Time Frame: Study duration ] [ Designated as safety issue: Yes ]
Changes in laboratory values [ Time Frame: Study duration ] [ Designated as safety issue: Yes ]
Incidence of anti-denosumab antibody (binding and neutralizing) formation [ Time Frame: Study duration ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Double-blind Study of Denosumab Compared With Zoledronic Acid in the Treatment of 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

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care

Condition ^ICMJE

Bone Metastases

Intervention ^ICMJE

Drug: zoledronic acid
4mg zoledronic acid IV over minimum 15 minutes Q4W

Other Name: Zometa
Biological: denosumab
120 mg SC Q4W

Study Arm (s)

Active Comparator: denosumab placebo with active zoledronic acid
Intervention: Drug: zoledronic acid
Active Comparator: denosumab with zoledronic acid placebo
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

Active, not recruiting

Enrollment ^ICMJE

1904

Estimated Completion Date

March 2012

Primary Completion Date

October 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

Gender

Male

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, 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

Administrative Information

NCT Number ^ICMJE

NCT00321620

Other Study ID Numbers ^ICMJE

20050103

Has Data Monitoring Committee

Not Provided

Responsible Party

Global Development Leader, Amgen Inc.

Study Sponsor ^ICMJE

Amgen

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Amgen

Information Provided By

Amgen

Verification Date

November 2010

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

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