Trial · NCT00051636
Safety and Efficacy Trial With Zoledronic Acid for the Treatment of Paget's Disease of Bone, Including an Extended Observation Period
NCT00051636, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2012-05-07
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Efficacy Trial With Zoledronic Acid for the Treatment of Paget's Disease of Bone, Including an Extended Observation Period. Trials, record NCT00051636. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00051636
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- 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
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 172 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Paget's Disease of Bone
- Interventions
- Zoledronic Acid, Risedronate, Placebo to Risedronate, Placebo to Zoledronic Acid, Calcium and Vitamin D
- First posted
- 2003-01-15
- Last updated
- 2012-05-15
- Results first posted
- 2012-05-07
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Patients Who Achieve Therapeutic Response at 6 Months. | 6 months | Therapeutic response is defined as a reduction of at least 75% from baseline (Visit 1) in total serum alkaline phosphatase excess (difference between measured level and midpoint to the normal range) or normalization of serum alkaline phosphatase at the end of six months. |
| Secondary | Relative Change in Serum Alkaline Phosphatase (SAP) in Units Per Liter (U/L) at Day 28 | Baseline and day 28 | The percent change in serum alkaline phosphatase from baseline to day 28 was measured. |
| Secondary | Relative Change in Serum C-telopeptide (CTx) in ng/mL at Day 10 | Baseline and day 10 | The percent change in serum C-telopeptide from baseline to day 10 was measured. |
| Secondary | Relative Change in Urine Alpha C-telopeptide (α-CTx) in ug/mmol at Day 10 | Baseline and day 10 | The percent change in urine alpha C-telopeptide from baseline to day 10 was measured. |
| Secondary | Time to First Therapeutic Response | 182 days | A therapeutic response was defined as a reduction of at least 75% from baseline (Visit 1) in serum alkaline phosphatase excess (difference between measured level and midpoint to the normal range) or normalization of serum alkaline phosphatase. |
| Secondary | Number of Patients Who Achieved Serum Alkaline Phosphatase Normalization at Day 28 Relative to Baseline | Baseline and day 28 | Normalization of serum alkaline phosphatase occurred if the serum alkaline phosphatase measurement fell within the normal range. |
| Secondary | Change in Pain Severity Score | Baseline and day 182 | Change in pain severity score from Brief Pain Inventory-Short Form (BPI-SF). This scale values are 0 to 10, a lower score means little to no pain while a higher score means greater pain. |
| Secondary | Change in Pain Interference Score | Baseline and day 182 | Change in pain interference score from Brief Pain Inventory-Short Form (BPI-SF). This scale values are 0 to 10, a lower score means little to no pain while a higher score means greater pain. |
| Secondary | Number of Participants With a Loss of Therapeutic Response During the Extended Observation Period | 8 years was the maximum | Extended observation period. A therapeutic response is defined as a reduction of at least 75% from baseline in serum alkaline phosphatase excess or normalization of serum alkaline phosphatase. |
| Secondary | Number of Participants With a Partial Disease Relapse During the Extended Observation Period | 8 years was the maximum | 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. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Patients Who Achieve Therapeutic Response at 6 Months. | 6 months | Modified intent to treat population: all randomized patients with both baseline and at least one post-baseline serum alkaline phosphatase measurement. Missing values at 6 months were imputed using the last post-baseline measurement prior to 6 months. | participants | NUMBER |
| SECONDARY | Relative Change in Serum Alkaline Phosphatase (SAP) in Units Per Liter (U/L) at Day 28 | Baseline and day 28 | Intent-to-treat population: all randomized patients. Participants with observations at baseline and 28 days were included in this analysis. | percent change | MEAN |
| SECONDARY | Relative Change in Serum C-telopeptide (CTx) in ng/mL at Day 10 | Baseline and day 10 | Intent-to-treat population: all randomized patients. Participants with observations at baseline and day 10 were included in this analysis. | percent change | MEAN |
| SECONDARY | Relative Change in Urine Alpha C-telopeptide (α-CTx) in ug/mmol at Day 10 | Baseline and day 10 | Intent-to-treat population: all randomized patients. Participants with observations at baseline and day 10 were included in this analysis. | Percent change | MEAN |
| SECONDARY | Time to First Therapeutic Response | 182 days | Intent-to-treat population: all randomized patients. | Days | MEDIAN |
| SECONDARY | Number of Patients Who Achieved Serum Alkaline Phosphatase Normalization at Day 28 Relative to Baseline | Baseline and day 28 | Intent-to-treat population: all randomized patients. Participants with observations at day 28 were included in this analysis. | Participants | NUMBER |
| SECONDARY | Change in Pain Severity Score | Baseline and day 182 | Intent-to-treat population: all randomized patients. Participants with observations at baseline and day 182 were included in this analysis. | Units on a scale | MEAN |
| SECONDARY | Change in Pain Interference Score | Baseline and day 182 | Intent-to-treat population: all randomized patients. Participants with observations at baseline and day 182 were included in this analysis. | Units on a scale | MEAN |
| SECONDARY | Number of Participants With a Loss of Therapeutic Response During the Extended Observation Period | 8 years was the maximum | Extended modified Intent-to-treat population: patients who had at least one serum alkaline phosphatase measurement during the extension period. | Participants | NUMBER |
| SECONDARY | Number of Participants With a Partial Disease Relapse During the Extended Observation Period | 8 years was the maximum | Extended modified Intent-to-treat population: patients who had at least one serum alkaline phosphatase measurement during the extension period. | Participants | NUMBER |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group22
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Patients Who Achieve Therapeutic Response at 6 Months. | Zoledronic Acid and Placebo to Risedronate | 85 | participants | ||
| Number of Patients Who Achieve Therapeutic Response at 6 Months. | Risedronate and Placebo to Zoledronic Acid | 60 | participants | ||
| Relative Change in Serum Alkaline Phosphatase (SAP) in Units Per Liter (U/L) at Day 28 | Zoledronic Acid and Placebo to Risedronate | -48.8 | Standard Deviation 11.51 | percent change | |
| Relative Change in Serum Alkaline Phosphatase (SAP) in Units Per Liter (U/L) at Day 28 | Risedronate and Placebo to Zoledronic Acid | -28.4 | Standard Deviation 17.72 | percent change | |
| Relative Change in Serum C-telopeptide (CTx) in ng/mL at Day 10 | Zoledronic Acid and Placebo to Risedronate | -85.4 | Standard Deviation 18.00 | percent change | |
| Relative Change in Serum C-telopeptide (CTx) in ng/mL at Day 10 | Risedronate and Placebo to Zoledronic Acid | -36.7 | Standard Deviation 69.58 | percent change | |
| Relative Change in Urine Alpha C-telopeptide (α-CTx) in ug/mmol at Day 10 | Zoledronic Acid and Placebo to Risedronate | -90.3 | Standard Deviation 13.19 | Percent change | |
| Relative Change in Urine Alpha C-telopeptide (α-CTx) in ug/mmol at Day 10 | Risedronate and Placebo to Zoledronic Acid | -29.9 | Standard Deviation 37.52 | Percent change | |
| Time to First Therapeutic Response | Zoledronic Acid and Placebo to Risedronate | 64 | Inter-Quartile Range 61 to 65 | Days | |
| Time to First Therapeutic Response | Risedronate and Placebo to Zoledronic Acid | 78 | Inter-Quartile Range 64 to 178 | Days |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Period 1 - Core | STARTED | Zoledronic Acid and Placebo to Risedronate | 90 | |
| Period 1 - Core | STARTED | Risedronate and Placebo to Zoledronic Acid | 82 | |
| Period 1 - Core | COMPLETED | Zoledronic Acid and Placebo to Risedronate | 86 | |
| Period 1 - Core | COMPLETED | Risedronate and Placebo to Zoledronic Acid | 76 | |
| Period 1 - Core | NOT COMPLETED | Zoledronic Acid and Placebo to Risedronate | 4 | |
| Period 1 - Core | NOT COMPLETED | Risedronate and Placebo to Zoledronic Acid | 6 | |
| Period 2- Extended Observation Period | STARTED | Zoledronic Acid and Placebo to Risedronate | 75 | |
| Period 2- Extended Observation Period | STARTED | Risedronate and Placebo to Zoledronic Acid | 52 | |
| Period 2- Extended Observation Period | COMPLETED | Zoledronic Acid and Placebo to Risedronate | 5 | |
| Period 2- Extended Observation Period | COMPLETED | Risedronate and Placebo to Zoledronic Acid | 22 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events94
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Constipation | Gastrointestinal disorders | Zoledronic Acid and Placebo to Risedronate | 5 | 89 | |
| other | Constipation | Gastrointestinal disorders | Risedronate and Placebo to Zoledronic Acid | 6 | 82 | |
| other | Diarrhoea | Gastrointestinal disorders | Zoledronic Acid and Placebo to Risedronate | 5 | 89 | |
| other | Diarrhoea | Gastrointestinal disorders | Risedronate and Placebo to Zoledronic Acid | 3 | 82 | |
| other | Dyspepsia | Gastrointestinal disorders | Zoledronic Acid and Placebo to Risedronate | 7 | 89 | |
| other | Dyspepsia | Gastrointestinal disorders | Risedronate and Placebo to Zoledronic Acid | 3 | 82 | |
| other | Nausea | Gastrointestinal disorders | Zoledronic Acid and Placebo to Risedronate | 10 | 89 | |
| other | Nausea | Gastrointestinal disorders | Risedronate and Placebo to Zoledronic Acid | 8 | 82 | |
| other | Fatigue | General disorders | Zoledronic Acid and Placebo to Risedronate | 8 | 89 | |
| other | Fatigue | General disorders | Risedronate and Placebo to Zoledronic Acid | 5 | 82 |
1 to 10 of 94Source ClinicalTrials.gov
See all 94 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Zoledronic Acid and Placebo to Risedronate | ||
| Total, all-cause mortality | Risedronate and Placebo to Zoledronic Acid | ||
| Total, other adverse events | Zoledronic Acid and Placebo to Risedronate | 71 | 89 |
| Total, other adverse events | Risedronate and Placebo to Zoledronic Acid | 58 | 82 |
| Total, serious adverse events | Zoledronic Acid and Placebo to Risedronate | 5 | 89 |
| Total, serious adverse events | Risedronate and Placebo to Zoledronic Acid | 8 | 82 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons6
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Zoledronic Acid and Placebo to Risedronate vs Risedronate and Placebo to Zoledronic Acid: Number of Patients Who Achieve Therapeutic Response at 6 Months. | Trial comparisons |
| Zoledronic Acid and Placebo to Risedronate vs Risedronate and Placebo to Zoledronic Acid: Number of Participants With a Loss of Therapeutic Response During the Extended Observation Period | Trial comparisons |
| Zoledronic Acid and Placebo to Risedronate vs Risedronate and Placebo to Zoledronic Acid: Number of Patients Who Achieved Serum Alkaline Phosphatase Normalization at Day 28 Relative to Baseline | Trial comparisons |
| 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 |
| Zoledronic Acid and Placebo to Risedronate vs Risedronate and Placebo to Zoledronic Acid: Number of Participants With a Disease Relapse During the Extended Observation Period | Trial comparisons |
| Zoledronic Acid and Placebo to Risedronate vs Risedronate and Placebo to Zoledronic Acid: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
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
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00051636
GET https://conductscience.org/api/trials/v1/NCT00051636/results?page=2