Denosumab 60 mg Q6M vs Placebo: Number of Participants With New Vertebral 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 | 0.0232 | 0.0188 | 0.0286 | wilson | ClinicalTrials.gov | |
| Risk in group 2 | 0.0715 | 0.0636 | 0.0803 | wilson | ClinicalTrials.gov | |
| Risk difference, group 1 minus group 2 | -0.0483 | -0.0581 | -0.0388 | newcombe hybrid score | ClinicalTrials.gov | |
| Risk ratio, group 1 over group 2 | 0.325 | 0.256 | 0.412 | log | ClinicalTrials.gov | |
| Odds ratio, group 1 over group 2 | 0.309 | 0.241 | 0.396 | log | ClinicalTrials.gov | |
| Number needed to treat, for one fewer participant with the outcome on Denosumab 60 mg Q6M than on Placebo | 20.7 | 17.2 | 25.8 | 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. | 86 | 3,702 | OG001 | ClinicalTrials.gov |
| Group 2 | Placebo | Placebo administered subcutaneously once every 6 months for 3 years. | 264 | 3,691 | OG000 | ClinicalTrials.gov |
Outcome 5
| Field | Value | Source |
|---|---|---|
| Type | PRIMARY | ClinicalTrials.gov |
| Title | Number of Participants With New Vertebral Fractures | ClinicalTrials.gov |
| 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 Baseline grade of 0 in any vertebra from T4 to L4. New vertebral fractures included morphometric vertebral fractures (assessed at scheduled visits and not associated with signs or symptoms \[or both\] indicative of a fracture) and clinical vertebral fractures (assessed at either a scheduled or unscheduled visit and associated with any signs and/or symptoms indicative of a fracture, excluding any fracture associated with high trauma severity or a pathologic fracture). | ClinicalTrials.gov |
| Time frame | 36 months | ClinicalTrials.gov |
| Population | Primary Efficacy Analysis Set, which includes all randomized participants who have a baseline and ≥ 1 postbaseline evaluation of vertebral fracture at or before 3 years. Last Observation Carried Forward was used. | 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.