A Randomized, Double-blinded, Multicenter Study of Denosumab Compared With Zoledronic acid (Zometa) in the Treatment of Bone Metastases in Subjects with Advanced Breast Cancer

Status

Unknown

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080220875

Enrollment

1960

Registered

2009-09-24

Start date

2009-09-24

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced breast cancer with bone metastases

Interventions

investigational material(s) Generic name etc : Denosumab INN of investigational material : Therapeutic category code : 399 Agents affecting metabolism, n.e.c. Dosage and Administration for Investigat

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Adult with histologically or cytologically confirmed breast adenocarcinoma, and radiographic evidence of at least 1 bone metastasis

Exclusion criteria

Exclusion criteria: -Current or prior IV bisphosphonate administration -Current of prior oral bisphosphonates for bone mets -Life expectancy of less than 6 months

Design outcomes

Primary

Measure	Time frame
Time to the first on-study SRE The Cox model is used for the analyses of time to the first on-study SRE	—

Secondary

Measure	Time frame
Time to the first-and-subsequent on-study SRE The Andersen and Gill approach is used for the analyses of time to the first-and-subsequent on-study SRE	—

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026