Safety and Efficacy Trial With Zoledronic Acid for the Treatment of Paget's Disease of Bone, Including an Extended Observation Period

May 29, 2012 updated by: Novartis Pharmaceuticals

Randomized, Double-Blind, Safety and Efficacy Trial With Intravenous Zoledronic Acid for the Treatment of Paget's Disease of Bone Using Risedronate as a Comparator, Including an Extended Observation Period

The primary objective of this core study was to show non-inferiority of zoledronic acid to risedronate, with respect to the proportion of patients who achieved therapeutic response. The extended observation period included participants of the core study who responded to treatment.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
185

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Fitzroy, Australia
        • Novartis Investigative Site
      • Kogarah, Australia
        • Novartis Investigative Site
      • Newcastle, Australia
        • Novartis Investigative Site
      • Parkville, Australia
        • Novartis Investigative Site
      • St. Leonards, Australia
        • Novartis Investigative Site
  • Belgium
      • Brussels, Belgium
        • Novartis Investigative Site
      • Gent, Belgium
        • Novartis Investigative Site
  • Canada
      • Montreal, Canada
        • Novartis Investigative Site
  • France
      • Angers, France
        • Novartis Investigative Site
      • Dreux Cedex, France
        • Novartis Investigative Site
      • Marseille, France
        • Novartis Investigative Site
      • Nice Cedex, France
        • Novartis Investigative Site
      • Paris Cedex, France
        • Novartis Investigative Site
      • Rouen Cedex, France
        • Novartis Investigative Site
      • Toulouse, France
        • Novartis Investigative Site
  • Germany
      • Berlin, Germany
        • Novartis Investigative Site
      • Frankfurt, Germany
        • Novartis Investigative Site
      • Leipzig, Germany
        • Novartis Investigative Site
      • Leverkusen, Germany
        • Novartis Investigative Site
      • Wirzburg, Germany
        • Novartis Investigative Site
  • New Zealand
      • Christchurch, New Zealand
        • Novartis Investigative Site
  • South Africa
      • Cape Town, South Africa
        • Novartis Investigative Site
  • Spain
      • Barcelona, Spain
        • Novartis Investigative Site
      • Madrid, Spain
        • Novartis Investigative Site
      • Malaga, Spain
        • Novartis Investigative Site
      • Salamanca, Spain
        • Novartis Investigative Site
      • Santiago de Compostela, Spain
        • Novartis Investigative Site
      • Valencia, Spain
        • Novartis Investigative Site
  • United Kingdom
      • Liverpool, United Kingdom
        • Novartis Investigative Site
      • London, United Kingdom
        • Novartis Investigative Site
      • Oxford, United Kingdom
        • Novartis Investigative Site
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85732
        • Novartis Investigative Site
    • Colorado
      • Colorado Springs, Colorado, United States, 80901
        • Novartis Investigative Site
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Novartis Investigative Site
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Novartis Investigative Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Novartis Investigative Site
    • New York
      • Syracuse, New York, United States, 13210
        • Novartis Investigative Site
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Novartis Investigative Site
    • Oregon
      • Medford, Oregon, United States, 97504
        • Novartis Investigative Site
    • South Carolina
      • Columbia, South Carolina, United States, 29209
        • Novartis Investigative Site
    • Wisconsin
      • Madison, Wisconsin, United States, 53592
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 30 years or older
  • SAP 2 times ULN
  • Confirmed diagnosis of Paget's disease of the bone (by x-ray, magnetic resonance imaging, computerized tomography, radioisotope imaging, etc.).
  • 90 days washout calcitonin
  • 180 day washout bisphosphonate

Exclusion Criteria:

  • Allergic reaction to bisphosphonates
  • History of upper GI disorders
  • History of iritis, uveitis
  • Calculated creatinine clearance < 30 ml/min at baseline
  • Evidence of vitamin D deficiency

Other protocol-defined inclusion/exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Drug: zoledronic acid
5 mg zoledronic acid in 5 mL of sterile water for infusion
Drug: Placebo to risedronate
oral capsules
Drug: Calcium and vitamin D supplements
Calcium and vitamin D supplements were supplied
Active Comparator: 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.
Drug: Calcium and vitamin D supplements
Calcium and vitamin D supplements were supplied
Drug: placebo to zoledronic acid
5 mL of sterile water for infusion
Drug: Risedronate
30mg oral tablets overencapsulated to match the placebo capsules

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Patients Who Had Therapeutic Response at 6 Months
Time Frame: Baseline, 6 months
A therapeutic response was defined as a reduction of at least 75% from baseline (Visit 1) in serum alkaline phosphatase (SAP) excess (difference between measured level and midpoint to the normal range) or normalization of SAP at the end of six months.
Baseline, 6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Relative Change in Serum Alkaline Phosphatase in U/L at Day 28
Time Frame: Baseline and 28 days
The percent change in serum alkaline phosphatase from baseline to Day 28 was measured.
Baseline and 28 days
Relative Change in Serum C-telopeptide (CTx) in ng/mL at Day 10
Time Frame: Baseline and day 10
The percent change in serum C-telopeptide from baseline to Day 10 was measured.
Baseline and day 10
Relative Change in Urine α-CTx in ug/mmol at Day 10
Time Frame: Baseline and day 10
The percent change in urine α-CTx from baseline to Day 10 was measured.
Baseline and day 10
Time to First Therapeutic Response
Time Frame: 182 days
Therapeutic response was defined as a reduction of at least 75% from baseline in serum alkaline phosphatase excess (difference between measured level and midpoint to the normal range) or normalization of serum alkaline phosphatase.
182 days
Number of Patients Who Achieved Serum Alkaline Phosphatase Normalization at Day 28
Time Frame: Day 28
Normalization of serum alkaline phosphatase occurred if the serum alkaline phosphatase measurement fell within the normal range. Central laboratory reference ranges for serum alkaline phosphatase: 31-110 U/L (female & male 20-58 years) and 35-115 U/L (female & male >58 years).
Day 28
Change in Pain Severity at Day 182
Time Frame: 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.
Baseline and day 182
Change in Pain Interference at Day 182
Time Frame: 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.
Baseline and day 182
Number of Participants With a Loss of Therapeutic Response During the Extended Observation Period
Time Frame: 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.
8 years was the maximum
Number of Participants With a Partial Disease Relapse During the Extended Observation Period
Time Frame: 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.
8 years was the maximum
Number of Participants With a Disease Relapse During the Extended Observation Period
Time Frame: 8 years was maximum
Extended observation period. A disease relapse was defined as the occurrence of a serum alkaline phosphatase level that was >= 80% of baseline serum alkaline phosphatase value.
8 years was maximum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2002

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2003

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 14, 2005

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 14, 2005

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 15, 2005

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 4, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 29, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CZOL446H2305
  • ZOL446K2305 (Other Identifier: Novartis Pharmaceuticals)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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