Comparison · NCT00439647-sae
Zoledronic Acid vs Placebo: 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. Zoledronic Acid vs Placebo: serious adverse events. Trial comparisons, record NCT00439647-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00439647-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 | 0.253 | 0.22 | 0.29 | wilson | |
| Risk in group 2 | 0.252 | 0.219 | 0.288 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00136 | -0.0477 | 0.0506 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.01 | 0.828 | 1.22 | log | |
| Odds ratio, group 1 over group 2 | 1.01 | 0.776 | 1.31 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Zoledronic Acid than on Placebo | 738 | 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 | Zoledronic Acid | 5 mg/100 ml administered via a peripheral intravenous site as a slow infusion over 15 minutes. The i.v. infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year | 149 | 588 | EG000 |
| Group 2 | Placebo | 100 ml Placebo administered via a peripheral intravenous site as a slow infusion over 15 minutes. The i.v. infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year | 154 | 611 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- Efficacy in Reducing Fractures and Safety of Zoledronic Acid in Men With Osteoporosis
- NCT number
- NCT00439647
- Phases
- PHASE3
- Conditions
- Male Osteoporosis
- Interventions
- Zoledronic acid 5 mg iv, Placebo
- Lead sponsor
- Novartis Pharmaceuticals
- Results first posted
- 2011-11-16
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00439647?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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