CompletedPhase 3

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

1,779 participantsStarted 2006-06-01

Plain-language 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)

Who can participate

Age range18 Years

SexALL

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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

What they're measuring

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

Timeframe: up to 33 months

Trial details

NCT IDNCT00330759

SponsorAmgen

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2009-04-01

Results submitted2010-12-09

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