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Comparison · NCT00051636-sae

Zoledronic Acid and Placebo to Risedronate vs Risedronate and Placebo to Zoledronic Acid: 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. Zoledronic Acid and Placebo to Risedronate vs Risedronate and Placebo to Zoledronic Acid: serious adverse events. Trial comparisons, record NCT00051636-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00051636-sae

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 10.05620.02420.125wilson
Risk in group 20.09760.05030.181wilson
Risk difference, group 1 minus group 2-0.0414-0.1310.042newcombe hybrid score
Risk ratio, group 1 over group 20.5760.1961.69log
Odds ratio, group 1 over group 20.5510.1731.76log
Number needed to treat, for one fewer participant with a serious adverse event on Zoledronic Acid and Placebo to Risedronate than on Risedronate and Placebo to Zoledronic Acid24.2from the risk difference intervalthe interval includes no difference

Groups2

Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Zoledronic Acid and Placebo to Risedronate
Participants received zoledronic acid 5 mg intravenous infusion one dose, 60 days of oral placebo to risedronate, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
589EG000
Group 2Risedronate and Placebo to Zoledronic Acid
Participants received 60 days of oral risedronate 30 mg, one intravenous infusion of placebo to zoledronic acid, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
882EG001

Harm

What it counts
Total, serious adverse events
Time frame

Source ClinicalTrials.gov

Trial

Title
Safety and Efficacy Trial With Zoledronic Acid for the Treatment of Paget's Disease of Bone, Including an Extended Observation Period
NCT number
NCT00051636
Phases
PHASE3
Conditions
Paget's Disease of Bone
Interventions
Zoledronic Acid, Risedronate, Placebo to Risedronate, Placebo to Zoledronic Acid, Calcium and Vitamin D
Lead sponsor
Novartis Pharmaceuticals
Results first posted
2012-05-07

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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