Denosumab 60 mg Q6M vs Placebo: Number of Participants With Nonvertebral Fractures
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
Measures 6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note | Source |
|---|---|---|---|---|---|---|
| Risk in group 1 | 0.061 | 0.0539 | 0.0689 | wilson | ClinicalTrials.gov | |
| Risk in group 2 | 0.075 | 0.0672 | 0.0837 | wilson | ClinicalTrials.gov | |
| Risk difference, group 1 minus group 2 | -0.014 | -0.0252 | -0.00285 | newcombe hybrid score | ClinicalTrials.gov | |
| Risk ratio, group 1 over group 2 | 0.813 | 0.689 | 0.959 | log | ClinicalTrials.gov | |
| Odds ratio, group 1 over group 2 | 0.801 | 0.671 | 0.956 | log | ClinicalTrials.gov | |
| Number needed to treat, for one fewer participant with the outcome on Denosumab 60 mg Q6M than on Placebo | 71.3 | 39.6 | 351 | from the risk difference interval | ClinicalTrials.gov |
Groups 2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code | Source |
|---|---|---|---|---|---|---|
| Group 1 | Denosumab 60 mg Q6M | Denosumab 60 mg administered subcutaneously once every 6 months (Q6M) for 3 years. | 238 | 3,902 | OG001 | ClinicalTrials.gov |
| Group 2 | Placebo | Placebo administered subcutaneously once every 6 months for 3 years. | 293 | 3,906 | OG000 | ClinicalTrials.gov |
Outcome 5
| Field | Value | Source |
|---|---|---|
| Type | SECONDARY | ClinicalTrials.gov |
| Title | Number of Participants With Nonvertebral Fractures | ClinicalTrials.gov |
| Description | Nonvertebral fractures (osteoporotic) were those occurring on study excluding those of the vertebrae (cervical, thoracic, and lumbar), skull, facial, mandible, metacarpus, finger phalanges, and toe phalanges. Fractures associated with high trauma severity (fractures that were the result of a fall from higher than the height of a stool, chair, first rung on a ladder or equivalent (\> 20 inches) or was the result of severe trauma other than a fall) and pathologic fractures were excluded from this category. Nonvertebral fractures were required to be confirmed either by radiographs or other diagnostic images such as computerized tomography (CT) or magnetic resonance imaging (MRI), or by documentation in a radiology report, surgical report, or discharge summary. | ClinicalTrials.gov |
| Time frame | 36 months | ClinicalTrials.gov |
| Population | Full analysis set (all randomized participants) | ClinicalTrials.gov |
Trial 8
| Field | Value | Source |
|---|---|---|
| Title | A Study to Evaluate Denosumab in the Treatment of Postmenopausal Osteoporosis | ClinicalTrials.gov |
| NCT number | NCT00089791 | ClinicalTrials.gov |
| Phases | PHASE3 | ClinicalTrials.gov |
| Conditions | Osteoporosis | ClinicalTrials.gov |
| Interventions | placebo, Denosumab | ClinicalTrials.gov |
| Lead sponsor | Amgen | ClinicalTrials.gov |
| Results first posted | 2014-01-10 | ClinicalTrials.gov |
| Results on ClinicalTrials.gov | https://clinicaltrials.gov/study/NCT00089791?tab=results | ClinicalTrials.gov |
Source 4
| Field | Value | Source |
|---|---|---|
| Release | trial-comparisons-2026-03-23-0.1.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57 | ClinicalTrials.gov |
| AACT copy | 2026-03-23 | ClinicalTrials.gov |
| 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 | ClinicalTrials.gov |
Release trial-comparisons-2026-03-23-0.1.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.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.
ClinicalTrials.gov: none 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.