Comparison · NCT00365456-sae
PTH (1-84) vs Risedronate: serious adverse events
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. PTH (1-84) vs Risedronate: serious adverse events. Trial comparisons, record NCT00365456-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00365456-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 | 0.0815 | 0.0586 | 0.112 | wilson | |
| Risk in group 2 | 0.113 | 0.0815 | 0.156 | wilson | |
| Risk difference, group 1 minus group 2 | -0.032 | -0.0801 | 0.0123 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.718 | 0.452 | 1.14 | log | |
| Odds ratio, group 1 over group 2 | 0.693 | 0.415 | 1.16 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on PTH (1-84) than on Risedronate | 31.3 | 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 | PTH (1-84) | Trial Period I SAEs and Trial Period III SAEs for subjects receiving PTH (1-84) | 33 | 405 | EG000 |
| Group 2 | Risedronate | Trial Period II SAEs and Trial Period III SAEs for subjects receiving risedronate | 32 | 282 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Over three years of the trial duration.
Source ClinicalTrials.gov
Trial
- Title
- Sequential Treatment of Postmenopausal Women With Primary Osteoporosis (FP-001-IM)
- NCT number
- NCT00365456
- Phases
- PHASE3
- Conditions
- Osteoporosis
- Interventions
- Parathyroid Hormone (PTH), Risedronate
- Lead sponsor
- Takeda
- Results first posted
- 2012-07-20
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00365456?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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