Trial · NCT00321464
A Study Comparing Denosumab vs. Zoledronic Acid for the Treatment of Bone Metastases in Breast Cancer Subjects.
NCT00321464, Phase 3, Completed, Amgen; results first posted 2014-03-10
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study Comparing Denosumab vs. Zoledronic Acid for the Treatment of Bone Metastases in Breast Cancer Subjects. Trials, record NCT00321464. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00321464
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study Comparing Denosumab vs. Zoledronic Acid for the Treatment of Bone Metastases in Breast Cancer Subjects.
- NCT number
- NCT00321464
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 2,049 participants, actual
- Lead sponsor
- Amgen
- Conditions
- Bone Metastases
- Interventions
- Denosumab, Zoledronic Acid
- First posted
- 2006-05-03
- Last updated
- 2022-11-08
- Results first posted
- 2014-03-10
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to First On-Study Skeletal Related Event (SRE) (Non-inferiority) | Up to 34 months | 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. |
| Secondary | Time to First On-Study Skeletal-Related Event (Superiority) | Up to 34 months | Time to first on-study skeletal-related event (SRE) using a superiority analysis. The median time to first skeletal-related event could not be estimated in one treatment arm, so the subject incidence is presented. |
| Secondary | Time to First and Subsequent On-Study Skeletal-Related Event | Up to 34 months | Time to first and subsequent on-study skeletal-related event (SRE) using a multiple event analysis. To be considered a subsequent SRE, the event must occur at least 21 days after the previous SRE. This outcome measure utilizes multiple event times, was analyzed based on a proportional mean model, and is therefore more appropriately summarized by the cumulative number of events. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time to First On-Study Skeletal Related Event (SRE) (Non-inferiority) | Up to 34 months | Full Analysis Set, composed of all randomized participants. | Participants | NUMBER |
| SECONDARY | Time to First On-Study Skeletal-Related Event (Superiority) | Up to 34 months | Full Analysis Set, composed of all randomized participants. | Participants | NUMBER |
| SECONDARY | Time to First and Subsequent On-Study Skeletal-Related Event | Up to 34 months | Full Analysis Set, composed of all randomized participants | Events | NUMBER |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time to First On-Study Skeletal Related Event (SRE) (Non-inferiority) | Zoledronic Acid | 372 | Participants | ||
| Time to First On-Study Skeletal Related Event (SRE) (Non-inferiority) | Denosumab | 315 | Participants | ||
| Time to First On-Study Skeletal-Related Event (Superiority) | Zoledronic Acid | 372 | Participants | ||
| Time to First On-Study Skeletal-Related Event (Superiority) | Denosumab | 315 | Participants | ||
| Time to First and Subsequent On-Study Skeletal-Related Event | Zoledronic Acid | 608 | Events | ||
| Time to First and Subsequent On-Study Skeletal-Related Event | Denosumab | 474 | Events |
Source ClinicalTrials.gov
Participant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Zoledronic Acid | 1,020 | |
| Overall Study | STARTED | Denosumab | 1,026 | |
| Overall Study | Received Investigational Product | Zoledronic Acid | 1,014 | |
| Overall Study | Received Investigational Product | Denosumab | 1,019 | |
| Overall Study | COMPLETED | Zoledronic Acid | 461 | |
| Overall Study | COMPLETED | Denosumab | 468 | |
| Overall Study | NOT COMPLETED | Zoledronic Acid | 559 | |
| Overall Study | NOT COMPLETED | Denosumab | 558 |
Source ClinicalTrials.gov
Adverse events1,180
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Zoledronic Acid 4 mg Q4W | 217 | 1,013 | |
| other | Anaemia | Blood and lymphatic system disorders | Denosumab 120 mg Q4W | 183 | 1,020 | |
| other | Leukopenia | Blood and lymphatic system disorders | Zoledronic Acid 4 mg Q4W | 72 | 1,013 | |
| other | Leukopenia | Blood and lymphatic system disorders | Denosumab 120 mg Q4W | 78 | 1,020 | |
| other | Neutropenia | Blood and lymphatic system disorders | Zoledronic Acid 4 mg Q4W | 118 | 1,013 | |
| other | Neutropenia | Blood and lymphatic system disorders | Denosumab 120 mg Q4W | 114 | 1,020 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Zoledronic Acid 4 mg Q4W | 53 | 1,013 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Denosumab 120 mg Q4W | 62 | 1,020 | |
| other | Abdominal pain | Gastrointestinal disorders | Zoledronic Acid 4 mg Q4W | 113 | 1,013 | |
| other | Abdominal pain | Gastrointestinal disorders | Denosumab 120 mg Q4W | 114 | 1,020 |
1 to 10 of 1,180Source ClinicalTrials.gov
See all 1,180 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Zoledronic Acid 4 mg Q4W | ||
| Total, all-cause mortality | Denosumab 120 mg Q4W | ||
| Total, other adverse events | Zoledronic Acid 4 mg Q4W | 941 | 1,013 |
| Total, other adverse events | Denosumab 120 mg Q4W | 924 | 1,020 |
| Total, serious adverse events | Zoledronic Acid 4 mg Q4W | 471 | 1,013 |
| Total, serious adverse events | Denosumab 120 mg Q4W | 453 | 1,020 |
Source ClinicalTrials.gov
Papers8
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Zoledronic Acid vs Denosumab: Time to First On-Study Skeletal-Related Event (Superiority) | Trial comparisons |
| Zoledronic Acid vs Denosumab: Time to First On-Study Skeletal Related Event (SRE) (Non-inferiority) | Trial comparisons |
| Zoledronic Acid 4 mg Q4W vs Denosumab 120 mg Q4W: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00321464
GET https://conductscience.org/api/trials/v1/NCT00321464/events?page=2