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

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: NCT00330759
Recruitment Status : Completed
First Posted : May 29, 2006
Results First Posted : April 9, 2014
Last Update Posted : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
Amgen

Study Description
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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 (lytic bone lesions from multiple myeloma) in subjects with advanced cancer and multiple myeloma (excluding breast and prostate cancer)

Condition or disease Intervention/treatment Phase
Bone Metastases Biological: Denosumab Drug: Zoledronic Acid Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1779 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: 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.
Actual Study Start Date : June 1, 2006
Actual Primary Completion Date : April 1, 2009
Actual Study Completion Date : October 1, 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: zoledronic acid
denosumab placebo with active zoledronic acid
 Drug: Zoledronic Acid
4 milligrams intravenous Zoledronic Acid over minimum 15 minutes every 4 weeks
Other Name: Zometa
Experimental: denosumab
active denosumab with zoledronic acid placebo
 Biological: Denosumab
120 milligrams by subcutaneous injection every 4 weeks


Outcome Measures
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Primary Outcome Measures :
  1. Time to the First On-Study Skeletal-Related Event (Non-Inferiority) [ Time Frame: up to 33 months ]
    Time to the first on-study skeletal-related event (SRE) using a non-inferiority analysis. Median was estimated using the Kaplan-Meier method.


Secondary Outcome Measures :
  1. Time to First On-Study Skeletal-Related Event (Superiority) [ Time Frame: up to 33 months ]
    Time to first on-study skeletal-related event (SRE) using a test for superiority. Median was estimated using the Kaplan-Meier method.

  2. Time to the First-and-Subsequent On-Study Skeletal-Related Event [ Time Frame: up to 33 months ]

    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.



Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00330759


Sponsors and Collaborators
Amgen
Investigators
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Study Director: MD Amgen
More Information
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Additional Information:

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00330759    
Other Study ID Numbers: 20050244
First Posted: May 29, 2006    Key Record Dates
Results First Posted: April 9, 2014
Last Update Posted: August 31, 2018
Last Verified: August 2018
Keywords provided by Amgen:
Bone metastases
lytic bone lesions
advanced cancer
multiple myeloma
lymphoma
solid tumors
 skeletal related events
skeletal fractures
spinal cord compressions, radiation to bone
surgery to bone, bisphosphonates
denosumab
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasm Metastasis
Neoplasms, Second Primary
Bone Neoplasms
Bone Marrow Diseases
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
 Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Neoplastic Processes
Pathologic Processes
Neoplasms by Site
Bone Diseases
Musculoskeletal Diseases
Zoledronic Acid
Denosumab
Bone Density Conservation Agents
Physiological Effects of Drugs