Comparison · NCT00556374-6eb12190
Denosumab vs Placebo: Number of Participants With New or Worsening Vertebral Fractures
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. Denosumab vs Placebo: Number of Participants With New or Worsening Vertebral Fractures. Trial comparisons, record NCT00556374-6eb12190. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00556374-6eb12190
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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 | 0.0371 | 0.0263 | 0.0522 | wilson | |
| Risk in group 2 | 0.068 | 0.0526 | 0.0875 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0309 | -0.0531 | -0.00931 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.546 | 0.355 | 0.839 | log | |
| Odds ratio, group 1 over group 2 | 0.529 | 0.337 | 0.83 | log | |
| Number needed to treat, for one fewer participant with the outcome on Denosumab than on Placebo | 32.4 | 18.8 | 107 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Denosumab | Participants randomized to receive 60 mg denosumab SC once Q6M in the double-blind phase. All participants continued to receive an approved non-steroidal aromatase inhibitor therapy. | 31 | 835 | OG001 |
| Group 2 | Placebo | Participants randomized to receive the matching placebo subcutaneously (SC) once every 6 months (Q6M) in the double-blind phase. All participants continued to receive an approved non-steroidal aromatase inhibitor therapy. | 55 | 809 | OG000 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With New or Worsening Vertebral Fractures
- Description
Assessment of vertebral fractures was performed by an expert radiologist at the central imaging center using a semiquantitative grading scale: Grade 1, 20% to 25% reduction in vertebral height (anterior, middle, or posterior); Grade 2, 25% to 40% reduction in height; Grade 3, greater than 40% reduction in height.~A new vertebral fracture was defined as a fracture in a previously undeformed vertebrae including new compression fractures, defined as those compression fractures having a decrease in total anterior or posterior height of at least 25% from baseline. New vertebral fractures includes morphometric vertebral fractures identified from on study x-rays and clinical vertebral fractures confirmed by x-rays. Worsening of pre-existing fractures was defined as an increase in fracture severity of at least 1 grade on the semiquantitative scale.
- Time frame
- 36 months
- Population
- Vertebral Fracture Analysis Set: all participants with a Baseline and at least one post-baseline vertebral x-ray prior to or at Month 36
Source ClinicalTrials.gov
Trial
- Title
- Study to Determine Treatment Effects of Denosumab in Patients With Breast Cancer Receiving Aromatase Inhibitor Therapy
- NCT number
- NCT00556374
- Phases
- PHASE3
- Conditions
- Breast Cancer
- Interventions
- Placebo, Denosumab, Non-steroidal aromatase inhibitor therapy, Zoledronic Acid, Standard of Care
- Lead sponsor
- Amgen
- Results first posted
- 2015-11-06
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00556374?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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