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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-002898-12 | EudraCT Number |
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The purpose of this study was to demonstrate that participants with Paget's disease of the bone who had responded to zoledronic acid treatment as participants in the core registration studies CZOL446K2304 and CZOL446K2305 and later experienced a relapse can be successfully treated with a 5 milligram (mg) infusion of zoledronic acid.
Uncontrolled study
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zoledronic Acid 5 mg | Experimental | Participants received single re-treatment dose of zoledronic acid 5 mg intravenous (IV) infusion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zoledronic Acid | Drug | Zoledronic acid 5 mg intravenous infusion once |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Serum Alkaline Phosphatase Within the Normal Range at Month 6 Last Observation Carried Forward (LOCF) | 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. | Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Change From Baseline in Serum Alkaline Phosphatase (SAP) Levels | The percentage change in SAP at Months 3 and 6 relative to baseline were measured. | Baseline, Months 3 and 6 |
| Percentage of Participants With SAP Within the Normal Range |
| Measure | Description | Time Frame |
|---|---|---|
| Collect Information Pertaining to Relapse Diagnosis to Define Retreatment Guidelines for Paget's Disease | 6 months |
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative site | Brussels | Belgium | ||||
| Novartis Investigative site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24422139 | Result | Reid IR, Brown JP, Levitt N, Roman Ivorra JA, Bachiller-Corral J, Ross IL, Su G, Antunez-Flores O, Aftring RP. Re-treatment of relapsed Paget's disease of bone with zoledronic acid: results from an open-label study. Bonekey Rep. 2013 Nov 6;2:442. doi: 10.1038/bonekey.2013.176. eCollection 2013. |
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A total of 6 participants from core studies CZOL44K2304 and CZOL44K2305 who met the definition of responders at the end of study visit but later relapsed during the extension of observation period took part in the study at 5 investigative sites in Canada, Spain, New Zealand and, South Africa from 21 October 2008 to 14 March 2011.
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| ID | Title | Description |
|---|---|---|
| FG000 | Zoledronic Acid 5 mg | Participants received single re-treatment dose of zoledronic acid 5 mg IV infusion. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Intent-to-Treat (ITT) Population included all enrolled participants who were previously randomized to zoledronic acid in the core studies (CZOL44K2304 and CZOL44K2305) and who received the intravenous study drug in this retreatment study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Zoledronic Acid 5 mg | Participants received single re-treatment dose of zoledronic acid 5 mg IV infusion. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Serum Alkaline Phosphatase Within the Normal Range at Month 6 Last Observation Carried Forward (LOCF) | 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Month 6 |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Zoledronic Acid 5 mg | Participants received single re-treatment dose of zoledronic acid 5 mg IV infusion. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Influenza | Infections and infestations | MedDRA (unspecified) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 | Novartis.email@novartis.com |
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| ID | Term |
|---|---|
| D010001 | Osteitis Deformans |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D000077211 | Zoledronic Acid |
| ID | Term |
|---|---|
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
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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.
| Months 3 and 6 |
| Number of Participants With At Least One or More Treatment-Emergent Adverse Events (TEAEs) | 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. | 6 months |
| Montreal |
| Canada |
| Novartis Investigative site | Québec | Canada |
| Novartis Investigative site | Auckland | New Zealand |
| Novartis Investigative site | Cape Town | South Africa |
| Novartis Investigative site | Barcelona | Spain |
| Novartis Investigative site | Madrid | Spain |
| Novartis Investigative site | Salamanca | Spain |
| Novartis Investigative site | Valencia | Spain |
| Novartis Investigative site | Nottingham | United Kingdom |
| Novartis Investigative site | Oxford | United Kingdom |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Baseline Serum Alkaline Phosphatase | Mean | Standard Deviation | Units/Liter (U/L) |
|
| Zoledronic Acid 5 mg |
Participants received single re-treatment dose of zoledronic acid 5 mg IV infusion. |
|
|
| Secondary | Percentage Change From Baseline in Serum Alkaline Phosphatase (SAP) Levels | The percentage change in SAP at Months 3 and 6 relative to baseline were measured. | 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. | Posted | Mean | Standard Error | percentage change | Baseline, Months 3 and 6 |
|
|
|
| Secondary | Percentage of Participants With SAP Within the Normal Range | 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. | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | Months 3 and 6 |
|
|
|
| Secondary | Number of Participants With At Least One or More Treatment-Emergent Adverse Events (TEAEs) | 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. | 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. | Posted | Count of Participants | Participants | 6 months |
|
|
|
| Other Pre-specified | Collect Information Pertaining to Relapse Diagnosis to Define Retreatment Guidelines for Paget's Disease | Not Posted | 6 months | Participants |
| 0 |
| 6 |
| 0 |
| 6 |
| 1 |
| 6 |
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
| D007093 |
| Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |