Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00330759 | Study of Denosumab vs. Zoledronic Acid to Treat Bone Metastases in Subjects With Advanced Cancer or Multiple Myeloma. | PHASE3 | COMPLETED | 1,779 | — | — | Jun 1, 2006 | Oct 1, 2011 | Nov 7, 2022 | - | — |
| NCT00321464 | A Study Comparing Denosumab vs. Zoledronic Acid for the Treatment of Bone Metastases in Breast Cancer Subjects. | PHASE3 | COMPLETED | 2,049 | — | — | Apr 1, 2006 | Apr 4, 2012 | Nov 8, 2022 | - | — |
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 (SRE) using a non-inferiority analysis. The median time to first skeletal-related event could not be estimated in one treatment arm, so the subject incidence is presented.
| Arm | Type | Description |
|---|---|---|
| zoledronic acid | ACTIVE_COMPARATOR | denosumab placebo with active zoledronic acid |
| denosumab | EXPERIMENTAL | active denosumab with zoledronic acid placebo |
| Name | Type | Description |
|---|---|---|
| Denosumab | BIOLOGICAL | 120 milligrams by subcutaneous injection every 4 weeks |
| Zoledronic Acid | DRUG | 4 milligrams intravenous Zoledronic Acid over minimum 15 minutes every 4 weeks |
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...