Comparison · NCT00103740-7f8aae21
Zoledronic Acid and Placebo to Risedronate vs Risedronate and Placebo to Zoledronic Acid: Number of Participants With a Partial Disease Relapse During the Extended Observation Period
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 and Placebo to Risedronate vs Risedronate and Placebo to Zoledronic Acid: Number of Participants With a Partial Disease Relapse During the Extended Observation Period. Trial comparisons, record NCT00103740-7f8aae21. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00103740-7f8aae21
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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 | 0.115 | 0.0619 | 0.205 | wilson | |
| Risk in group 2 | 0.587 | 0.464 | 0.7 | wilson | |
| Risk difference, group 1 minus group 2 | -0.472 | -0.597 | -0.32 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.196 | 0.103 | 0.376 | log | |
| Odds ratio, group 1 over group 2 | 0.0917 | 0.0389 | 0.216 | log | |
| Number needed to treat, for one fewer participant with the outcome on Zoledronic Acid and Placebo to Risedronate than on Risedronate and Placebo to Zoledronic Acid | 2.12 | 1.67 | 3.13 | from the risk difference interval |
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 | Zoledronic Acid and Placebo to Risedronate | Participants received zoledronic acid 5.0 mg i.v. infusion one dose, 60 days of oral placebo to risedronate, calcium 500mg bid and vitamin D 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period. | 9 | 78 | OG000 |
| Group 2 | Risedronate and Placebo to Zoledronic Acid | Participants received 60 days of oral risedronate 30 mg, one i.v. infusion of placebo to zoledronic acid infusion, calcium 500mg bid and vitamin d 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period. | 37 | 63 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With a Partial Disease Relapse During the Extended Observation Period
- Description
Extended observation period. A partial disease relapse was defined as an increase in serum alkaline phosphatase \>= 50% from the serum alkaline phosphatase measurement at Month 6 and at least 1.25 times the upper normal limit.
- Time frame
- 8 years was the maximum
- Population
- Extended modified Intent-to-treat population: patients who had at least one serum alkaline phosphatase measurement during the extension period.
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
- NCT00103740
- Phases
- PHASE3
- Conditions
- Paget's Disease of Bone
- Interventions
- zoledronic acid, placebo to zoledronic acid, Risedronate, Placebo to risedronate, Calcium and vitamin D supplements
- Lead sponsor
- Novartis Pharmaceuticals
- Results first posted
- 2012-05-02
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00103740?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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