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

Phase 3

Completed

• Conditions: Bone Metastases
• Interventions: Biological: Denosumab; Drug: Zoledronic Acid

• Registration Number: NCT00330759
• Lead Sponsor: Amgen

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)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-05-25
• Study First Submitted QC: 2006-05-25
• Study First Posted: 2006-05-29
• Study Start: 2006-06-01
• Primary Completion: 2009-04-01
• Disposition First Submitted: 2010-06-29
• Disposition First Submitted QC: 2010-06-29
• Disposition First Posted: 2010-07-01
• Results First Submitted: 2010-12-09
• Study Completion: 2011-10-01
• Results First Submitted QC: 2014-03-04
• Results First Posted: 2014-04-09
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-04
• Last Update Posted: 2022-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1779

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
denosumab	Denosumab	active denosumab with zoledronic acid placebo
zoledronic acid	Zoledronic Acid	denosumab placebo with active zoledronic acid

Primary Outcome Measures

Name	Time	Method
Time to the First On-Study Skeletal-Related Event (Non-Inferiority)	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

Name	Time	Method
Time to the First-and-Subsequent On-Study Skeletal-Related Event	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.
Time to First On-Study Skeletal-Related Event (Superiority)	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.