Study of Denosumab vs. Zoledronic Acid to Treat Bone Metastases in Subjects With Advanced Cancer or Multiple Myeloma.
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ClinicalTrials.gov Identifier: NCT00330759 |
Recruitment Status :
Completed
First Posted : May 29, 2006
Results First Posted : April 9, 2014
Last Update Posted : August 31, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Bone Metastases | Biological: Denosumab Drug: Zoledronic Acid | Phase 3 |
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 |

Arm | Intervention/treatment |
---|---|
Active Comparator: zoledronic acid
denosumab placebo with active zoledronic acid
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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
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Biological: Denosumab
120 milligrams by subcutaneous injection every 4 weeks |
- 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.
- 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.
- 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.

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

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
Study Director: | MD | Amgen |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 |
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 |
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 |