Comparison · NCT00529373-5d9bb979
Odanacatib 50 mg OW vs Placebo (Originally Assigned to Placebo): Second Extension: Number of Participants Who Experienced an Adverse Event
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. Odanacatib 50 mg OW vs Placebo (Originally Assigned to Placebo): Second Extension: Number of Participants Who Experienced an Adverse Event. Trial comparisons, record NCT00529373-5d9bb979. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00529373-5d9bb979
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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 | 0.691 | 0.675 | 0.707 | wilson | |
| Risk in group 2 | 0.687 | 0.668 | 0.706 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00385 | -0.0209 | 0.0288 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.01 | 0.97 | 1.04 | log | |
| Odds ratio, group 1 over group 2 | 1.02 | 0.907 | 1.14 | log | |
| Number needed to treat, for one more participant with the outcome on Odanacatib 50 mg OW than on Placebo (Originally Assigned to Placebo) | 260 | 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 | Odanacatib 50 mg OW | Participants received 50 mg of blinded odanacatib weekly over the course of the base study and first extension study (5 years total). This was to be followed by 50 mg of open-label odanacatib weekly for up to 5 years. Participants also received Vitamin D3 and open-label supplemental calcium so that total daily calcium intake (from both dietary and supplemental sources) was approximately 1200 mg. | 2,173 | 3,144 | OG000 |
| Group 2 | Placebo (Originally Assigned to Placebo) | Participants received blinded placebo to 50 mg of odanacatib weekly over the course of the base study and first extension study (5 years total). This was to be followed by 50 mg of open-label odanacatib weekly for up to 5 years. Participants also received Vitamin D3 and open-label supplemental calcium so that total daily calcium intake (from both dietary and supplemental sources) was approximately 1200 mg. | 1,587 | 2,309 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Second Extension: Number of Participants Who Experienced an Adverse Event
- Description
An adverse event is defined as any untoward medical occurrence in a person or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
- Time frame
- Up to approximately 34 months of observation
- Population
- The All-Participants-as-Treated population including all randomized participants who took at least one dose of study medication was used for the analysis (second extension study).
Source ClinicalTrials.gov
Trial
- Title
- A Study of MK-0822 in Postmenopausal Women With Osteoporosis to Assess Fracture Risk (MK-0822-018)
- NCT number
- NCT00529373
- Phases
- PHASE3
- Conditions
- Postmenopausal Osteoporosis
- Interventions
- Odanacatib, Placebo for Odanacatib, Vitamin D3, Calcium carbonate
- Lead sponsor
- Merck Sharp & Dohme LLC
- Results first posted
- 2019-11-14
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00529373?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.govNone 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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