Comparison · NCT00523341-b7aed1a7
Denosumab / Denosumab vs Placebo / Denosumab: Number of Participants With Non-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 / Denosumab vs Placebo / Denosumab: Number of Participants With Non-Vertebral Fractures. Trial comparisons, record NCT00523341-b7aed1a7. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00523341-b7aed1a7
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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 | 0.0734 | 0.0635 | 0.0847 | wilson | |
| Risk in group 2 | 0.0992 | 0.0874 | 0.112 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0258 | -0.0423 | -0.00951 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.74 | 0.611 | 0.896 | log | |
| Odds ratio, group 1 over group 2 | 0.719 | 0.584 | 0.886 | log | |
| Number needed to treat, for one fewer participant with the outcome on Denosumab / Denosumab than on Placebo / Denosumab | 38.7 | 23.6 | 105 | 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 / Denosumab | Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment). | 172 | 2,343 | OG001 |
| Group 2 | Placebo / Denosumab | Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study. | 219 | 2,207 | OG000 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Non-Vertebral Fractures
- Description
Non-vertebral fractures (osteoporotic) were defined as a fracture present on a copy of radiographs or other diagnostic images such as computerized tomography (CT) or magnetic resonance imaging (MRI) confirming the fracture, and/or documented in a copy of the radiology report, surgical report, or discharge summary, excluding skull, facial, mandible, cervical vertebrae, thoracic vertebrae, lumbar vertebrae, metacarpus, finger phalanges, and toe phalanges. In addition, fractures associated with high trauma severity or pathologic fractures were excluded.
- Time frame
- 84 months
- Population
- All enrolled participants
Source ClinicalTrials.gov
Trial
- Title
- Extension Study to Evaluate the Long Term Safety and Efficacy of Denosumab in the Treatment of Osteoporosis
- NCT number
- NCT00523341
- Phases
- PHASE3
- Conditions
- Osteopenia, Osteoporosis
- Interventions
- Denosumab
- Lead sponsor
- Amgen
- Results first posted
- 2016-07-12
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00523341?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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