Phase 3 Completed N=1,776 Randomized Double-blind Supportive Care

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

bone metastases

Source: ClinicalTrials.gov NCT00330759 ↗

Enrolled (actual)

1,776

Serious AEs

64.5%

Results posted

Apr 2014

Primary outcomePrimary: Time to the First On-Study Skeletal-Related Event (Non-Inferiority) — 496.0; 625.0 Days — p=0.0007

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)

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

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

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.