Comparison · NCT00205777-d1fda24f
Placebo (Core+SE I+SE II) vs Bazedoxifene 20 mg (SE II): Number of Participants With Worsening Vertebral Fractures Through Month 84
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. Placebo (Core+SE I+SE II) vs Bazedoxifene 20 mg (SE II): Number of Participants With Worsening Vertebral Fractures Through Month 84. Trial comparisons, record NCT00205777-d1fda24f. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00205777-d1fda24f
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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 | 0.000574 | 0.000101 | 0.00325 | wilson | |
| Risk in group 2 | 0.00205 | 0.000995 | 0.00423 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00148 | -0.00371 | 0.0014 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.28 | 0.0345 | 2.27 | log | |
| Odds ratio, group 1 over group 2 | 0.279 | 0.0343 | 2.27 | log | |
| Number needed to treat, for one fewer participant with the outcome on Placebo (Core+SE I+SE II) than on Bazedoxifene 20 mg (SE II) | 676 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Placebo (Core+SE I+SE II) | Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. | 1 | 1,741 | OG000 |
| Group 2 | Bazedoxifene 20 mg (SE II) | Participants from Bazedoxifene 20 mg and Bazedoxifene 40/20 mg treatment arm received bazedoxifene 20 mg capsule orally once daily for further 2 years in study extension II, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily. | 7 | 3,410 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Worsening Vertebral Fractures Through Month 84
- Description
A worsening vertebral fracture was defined as a decrease in anterior, mid, or posterior vertebral height of at least 20% and at least 4 mm as evaluated by quantitative morphometric assessment, and a grade change of at least 1 as rated by a radiologist using the semi-quantitative rating scale. It can occur only in a vertebra that was fractured at baseline.
- Time frame
- Baseline through Month 84
- Population
mITT population of SP1 population included all randomized participants who took at least 1 dose of test article and who had a vertebral radiographic assessment at baseline and at least once while on therapy. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
Source ClinicalTrials.gov
Trial
- Title
- Study Evaluating Bazedoxifene Acetate In Osteoporosis In Postmenopausal Women
- NCT number
- NCT00205777
- Phases
- PHASE3
- Conditions
- Osteoporosis
- Interventions
- Bazedoxifene Acetate, Placebo
- Lead sponsor
- Pfizer
- Results first posted
- 2013-04-10
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00205777?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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