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Study Complete
Sponsor ID
20050244

Study of denosumab vs. zoledronic acid to treat bone metastases in subjects with advanced cancer or multiple myeloma.

Sponsor ID
20050244
Clinicaltrials.gov ID
NCT00330759
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

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)

Additional Study Details

Phase
Phase 3
Product
denosumab
Type
Interventional
Masking
Double (Participant, Investigator)
Enrollment
1779
Additional Study Details

Protocol Summary

Primary Outcome Measures

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

Timeframe: up to 33 months

Secondary Outcome Measures

Time to First On-Study Skeletal-Related Event (Superiority)

Timeframe: up to 33 months

Time to the First-and-Subsequent On-Study Skeletal-Related Event

Timeframe: up to 33 months

Study Documents

Study Synopsis
Available Language(s): English
Download Document(s)

Locations

No locations found.
Study Info
Age
18+ years
Condition
  • Advanced/Metastatic Cancer
    • Sex
    All
    Trial Dates
    Jun 2006 - Apr 2009
    Inclusion and Exclusion 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