Phase 3
N=1,776
Study of Denosumab vs. Zoledronic Acid to Treat Bone Metastases in Subjects With Advanced Cancer or Multiple Myeloma.
Bone Metastases
Bottom Line
View on ClinicalTrials.gov: NCT00330759 ↗Enrolled (actual)
1,776
Serious AEs
64.5%
Results posted
Apr 2014
Primary outcome: Primary: Time to the First On-Study Skeletal-Related Event (Non-Inferiority) — 496.0; 625.0 Days — p=0.0007
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Denosumab (Biological); Zoledronic Acid (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Amgen
- Primary completion
- Apr 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to the First On-Study Skeletal-Related Event (Non-Inferiority) |
496.0; 625.0 | 0.0007 sig |
| SECONDARY Time to First On-Study Skeletal-Related Event (Superiority) |
496.0; 625.0 | 0.060 |
| SECONDARY Time to the First-and-Subsequent On-Study Skeletal-Related Event |
436; 392 | 0.145 |
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)
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00330759). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.