Comparison · NCT00523341-445acbb0
Denosumab / Denosumab vs Placebo / Denosumab: Number of Participants With New Vertebral Fractures
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Denosumab / Denosumab vs Placebo / Denosumab: Number of Participants With New Vertebral Fractures. Trial comparisons, record NCT00523341-445acbb0. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00523341-445acbb0
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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 | 0.0704 | 0.0603 | 0.0821 | wilson | |
| Risk in group 2 | 0.0728 | 0.0622 | 0.0851 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00241 | -0.0183 | 0.0134 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.967 | 0.776 | 1.21 | log | |
| Odds ratio, group 1 over group 2 | 0.964 | 0.761 | 1.22 | log | |
| Number needed to treat, for one fewer participant with the outcome on Denosumab / Denosumab than on Placebo / Denosumab | 415 | from the risk difference interval | the interval includes no difference |
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). | 149 | 2,116 | 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. | 145 | 1,991 | OG000 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With New Vertebral Fractures
- Description
A new vertebral fracture, assessed by lateral spine X-ray using Genant semiquantitative scoring method, was identified as an ≥ 1 grade increase from the previous grade of 0 in any vertebra from T4 to L4, excluding any fracture associated with high trauma severity or a pathologic fracture.
- Time frame
- 84 months
- Population
- All participants enrolled in the extension study who have vertebral X-ray assessment at the extension baseline and at least 1 post-extension baseline visit.
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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