Trial · NCT00740129
Re-treatment of Participants With Paget's Disease Using Zoledronic Acid
NCT00740129, Phase 4, Completed, Novartis Pharmaceuticals; results first posted 2021-05-26
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Re-treatment of Participants With Paget's Disease Using Zoledronic Acid. Trials, record NCT00740129. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00740129
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Re-treatment of Participants With Paget's Disease Using Zoledronic Acid
- NCT number
- NCT00740129
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 6 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Paget's Disease of the Bone
- Interventions
- Zoledronic Acid
- First posted
- 2008-08-22
- Last updated
- 2021-05-26
- Other registries' IDs
- eudract:2008-002898-12
- Results first posted
- 2021-05-26
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Serum Alkaline Phosphatase Within the Normal Range at Month 6 Last Observation Carried Forward (LOCF) | Month 6 | Normalization of serum alkaline phosphatase (SAP) occurred if the SAP measurement fell within the normal ranges. The lower and upper limits of normal ranges were 31 and 110 Units/Liter (U/L) for participants with age ≤ 58 years old and 35 and 115 U/L for participants with age \> 58 years old, respectively. Last observation carried forward (LOCF) was defined as the last post-baseline SAP value prior to month 6 for a participant who did not have an SAP value at month 6. |
| Secondary | Percentage Change From Baseline in Serum Alkaline Phosphatase (SAP) Levels | Baseline, Months 3 and 6 | The percentage change in SAP at Months 3 and 6 relative to baseline were measured. |
| Secondary | Percentage of Participants With SAP Within the Normal Range | Months 3 and 6 | Normalization of SAP occurred if the SAP measurement fell within the normal ranges. The lower and upper limits of normal ranges were 31 and 110 Units/Liter (U/L) for participants with age ≤ 58 years old and 35 and 115 U/L for participants with age \> 58 years old, respectively. |
| Secondary | Number of Participants With At Least One or More Treatment-Emergent Adverse Events (TEAEs) | 6 months | Adverse event was the appearance or worsening of any undesirable sign, symptom, or medical condition that occurred after starting the study drug even if the event was not considered to be related to study drug. TEAEs were defined as AEs that were absent prior to, but occurred after the i.v. infusion of study drug. TEAEs also included those that were present prior to the i.v. study drug infusion (i.e., as part of the extended observation period) but occurred at an increased severity after the i.v. infusion of study drug. |
| Other | Collect Information Pertaining to Relapse Diagnosis to Define Retreatment Guidelines for Paget's Disease | 6 months |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Serum Alkaline Phosphatase Within the Normal Range at Month 6 Last Observation Carried Forward (LOCF) | Month 6 | Modified Intent-to-Treat (MITT) Population included all enrolled participants who were previously randomized to zoledronic acid in the core studies (CZOL44K2304 and CZOL44K2305) and received the intravenous study drug and had baseline and at least one post-baseline assessment of the serum SAP in this retreatment study. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage Change From Baseline in Serum Alkaline Phosphatase (SAP) Levels | Baseline, Months 3 and 6 | MITT Population included all enrolled participants who were previously randomized to zoledronic acid in the core studies (CZOL44K2304 and CZOL44K2305) and received the intravenous study drug and had baseline and at least one post-baseline assessment of the serum SAP in this retreatment study. | percentage change | MEAN |
| SECONDARY | Percentage of Participants With SAP Within the Normal Range | Months 3 and 6 | MITT Population included all enrolled participants who were previously randomized to zoledronic acid in the core studies (CZOL44K2304and CZOL44K2305) and received the intravenous study drug and had baseline and at least one post-baseline assessment of the serum SAP in this retreatment study. | percentage of participants | NUMBER |
| SECONDARY | Number of Participants With At Least One or More Treatment-Emergent Adverse Events (TEAEs) | 6 months | Safety Population included all enrolled participants previously randomized to zoledronic acid in the core studies (CZOL44K2304 and CZOL44K2305) who received intravenous study drug in this retreatment study. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Collect Information Pertaining to Relapse Diagnosis to Define Retreatment Guidelines for Paget's Disease | 6 months |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Serum Alkaline Phosphatase Within the Normal Range at Month 6 Last Observation Carried Forward (LOCF) | Zoledronic Acid 5 mg | 83.3 | 95% Confidence Interval 35.9 to 99.6 | Percentage of Participants | |
| Percentage Change From Baseline in Serum Alkaline Phosphatase (SAP) Levels | Zoledronic Acid 5 mg | Percentage Change From Baseline in SAP Level at Month 3 | -53.12 | Standard Error 7.607 | percentage change |
| Percentage Change From Baseline in Serum Alkaline Phosphatase (SAP) Levels | Zoledronic Acid 5 mg | Percentage Change From Baseline in SAP Level at Month 6 | -49.51 | Standard Error 10.090 | percentage change |
| Percentage of Participants With SAP Within the Normal Range | Zoledronic Acid 5 mg | Month 3 | 100.0 | 95% Confidence Interval 54.1 to 100.0 | percentage of participants |
| Percentage of Participants With SAP Within the Normal Range | Zoledronic Acid 5 mg | Month 6 | 83.3 | 95% Confidence Interval 35.9 to 99.6 | percentage of participants |
| Number of Participants With At Least One or More Treatment-Emergent Adverse Events (TEAEs) | Zoledronic Acid 5 mg | 1 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Zoledronic Acid 5 mg | 6 | |
| Overall Study | COMPLETED | Zoledronic Acid 5 mg | 6 | |
| Overall Study | NOT COMPLETED | Zoledronic Acid 5 mg | 0 |
Source ClinicalTrials.gov
Adverse events1
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 | Influenza | Infections and infestations | Zoledronic Acid 5 mg | 1 | 6 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Zoledronic Acid 5 mg | 0 | 6 |
| Total, other adverse events | Zoledronic Acid 5 mg | 1 | 6 |
| Total, serious adverse events | Zoledronic Acid 5 mg | 0 | 6 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 24422139 | RESULT |
Source PubMed
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT00740129
GET https://conductscience.org/api/trials/v1/NCT00740129/registered