Comparison · NCT00545363-sae
BMF Participants vs No BMF Participants: serious adverse events
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. BMF Participants vs No BMF Participants: serious adverse events. Trial comparisons, record NCT00545363-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00545363-sae
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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 | 0.0226 | 0.0115 | 0.044 | wilson | |
| Risk in group 2 | 0.014 | 0.006 | 0.0324 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00859 | -0.0129 | 0.0314 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.61 | 0.533 | 4.88 | log | |
| Odds ratio, group 1 over group 2 | 1.63 | 0.527 | 5.02 | log | |
| Number needed to harm, for one more participant with a serious adverse event on BMF Participants than on No BMF Participants | 116 | 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 | BMF Participants | Postmenopausal women received ibandronate 150 mg QM orally for 6 months. Participants, in this arm, received BMF at Month 3. BMF was given in terms of providing serum CTX level at Month 3. A BMF-form was provided to the physicians to allow offering the bone marker result in an easy way. Participants were informed that their results were within or outside of the desired range. In addition, participants were also supported by PRP, carried out by supplying alarm devices, specifically designed to support the participant's regular drug intake. | 8 | 354 | EG000 |
| Group 2 | No BMF Participants | Postmenopausal women received ibandronate 150 mg QM orally for 6 months. Participants were supported by PRP, carried out by supplying alarm devices, specifically designed to support the participant's regular drug intake. | 5 | 357 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 15-30 days after final visit (final visit=up to 6 months)
Source ClinicalTrials.gov
Trial
- Title
- A Study of Adherence to Once Monthly Ibandronate (Bonviva) in Women With Post-Menopausal Osteoporosis, Supported by a Patient Relationship Program (PRP)
- NCT number
- NCT00545363
- Phases
- PHASE4
- Conditions
- Postmenopausal Osteoporosis
- Interventions
- Ibandronate
- Lead sponsor
- Hoffmann-La Roche
- Results first posted
- 2016-10-24
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00545363?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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