Study of Denosumab vs. Zoledronic Acid to Treat Bone Metastases in Subjects With Advanced Cancer or Multiple Myeloma.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00330759
First received: May 25, 2006
Last updated: July 14, 2014
Last verified: July 2014

May 25, 2006
July 14, 2014
June 2006
April 2009   (final data collection date for primary outcome measure)
Time to the First On-Study Skeletal-Related Event (Non-Inferiority) [ Time Frame: up to 33 months ] [ Designated as safety issue: No ]
Time to the first on-study skeletal-related event (SRE) using a non-inferiority analysis. Median was estimated using the Kaplan-Meier method.
Not Provided
Complete list of historical versions of study NCT00330759 on ClinicalTrials.gov Archive Site
  • Time to First On-Study Skeletal-Related Event (Superiority) [ Time Frame: up to 33 months ] [ Designated as safety issue: No ]
    Time to first on-study skeletal-related event (SRE) using a test for superiority. Median was estimated using the Kaplan-Meier method.
  • Time to the First-and-Subsequent On-Study Skeletal-Related Event [ Time Frame: up to 33 months ] [ Designated as safety issue: No ]

    Time to the first-and-subsequent on-study skeletal-related event (SRE) using multiple event analysis. To be considered a subsequent SRE, 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 Subjects With Advanced Cancer or Multiple Myeloma.
A Randomized, Double-Blind, Multicenter Study of Denosumab Compared With Zoledronic Acid (Zometa) in the Treatment of Bone Metastases in Subjects With Advanced Cancer (Excluding Breast and Prostate Cancer) or Multiple Myeloma.

The purpose of this study is to determine if denosumab is non-inferior to zoledronic acid (Zometa®) in the treatment of bone metastases (lytic bone lesions from multiple myeloma) in subjects with advanced cancer and multiple myeloma (excluding breast and prostate cancer)

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Bone Metastases
  • Biological: Denosumab
    120 milligrams by subcutaneous injection every 4 weeks
  • Drug: Zoledronic Acid
    4 milligrams intravenous Zoledronic Acid over minimum 15 minutes every 4 weeks
    Other Name: Zometa
  • Active Comparator: zoledronic acid
    denosumab placebo with active zoledronic acid
    Intervention: Drug: Zoledronic Acid
  • Experimental: denosumab
    active denosumab with zoledronic acid placebo
    Intervention: Biological: Denosumab

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1779
October 2011
April 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adults with histologically/cystologically confirmed advanced cancers including solid tumors, multiple myeloma, and lymphoma
  • Radiographic evidence of at least one bone metastasis (or lytic bone lesion from multiple myeloma); ECOG performance status 0, 1, or 2
  • Adequate organ function

Exclusion Criteria:

  • Diagnosis of breast or prostate cancer
  • Current or prior intravenous bisphosphonate administration
  • Current or prior oral bisphosphonates for bone metastases, life expectancy of less than 6 months
  • Prior history or current evidence of osteonecrosis/osteomyelitis of the jaw
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00330759
20050244
Yes
Amgen
Amgen
Not Provided
Study Director: MD Amgen
Amgen
July 2014

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