Comparison · NCT00321464-9e819e13
Zoledronic Acid vs Denosumab: Time to First On-Study Skeletal Related Event (SRE) (Non-inferiority)
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Zoledronic Acid vs Denosumab: Time to First On-Study Skeletal Related Event (SRE) (Non-inferiority). Trial comparisons, record NCT00321464-9e819e13. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00321464-9e819e13
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.365 | 0.336 | 0.395 | wilson | |
| Risk in group 2 | 0.307 | 0.28 | 0.336 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0577 | 0.0168 | 0.0984 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.19 | 1.05 | 1.34 | log | |
| Odds ratio, group 1 over group 2 | 1.3 | 1.08 | 1.56 | log | |
| Number needed to treat, for one more participant with the outcome on Zoledronic Acid than on Denosumab | 17.3 | 10.2 | 59.7 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Zoledronic Acid | Zoledronic acid 4 mg by intravenous injection with subcutaneous denosumab placebo once every 4 weeks | 372 | 1,020 | OG000 |
| Group 2 | Denosumab | Denomsumab 120 mg subcutaneously with intravenous zoledronic acid placebo once every 4 weeks | 315 | 1,026 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Time to First On-Study Skeletal Related Event (SRE) (Non-inferiority)
- Description
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.
- Time frame
- Up to 34 months
- Population
- Full Analysis Set, composed of all randomized participants.
Source ClinicalTrials.gov
Trial
- Title
- A Study Comparing Denosumab vs. Zoledronic Acid for the Treatment of Bone Metastases in Breast Cancer Subjects.
- NCT number
- NCT00321464
- Phases
- PHASE3
- Conditions
- Bone Metastases
- Interventions
- Denosumab, Zoledronic Acid
- Lead sponsor
- Amgen
- Results first posted
- 2014-03-10
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00321464?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
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
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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