Continued Efficacy and Safety of Zoledronic Acid (q 4 Wks vs. q 12 Wks) in the 2nd Year of Treatment in Patients With Bone Metastases From Breast Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00320710
First received: April 28, 2006
Last updated: August 18, 2014
Last verified: August 2014
Results First Received: July 8, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Breast Cancer
Interventions: Drug: Zoledronic acid
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The initial study design contained 3 arms: zoledronic acid q4 weeks, zoledronic acid q12 weeks and placebo q4 weeks. Due to a study amendment, the placebo arm was discontinued and participants in this treatment group were switched to the zoledronic acid q4 week group. These participants were not included in the efficacy analysis.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Zoledronic Acid Every (q) 4 Weeks Participants received 4mg of zoledronic acid intravenously (IV) infusion q 4 weeks.
Zoledronic Acid q 12 Weeks Participants received 4 mg zoledronic acid IV q 12 weeks and received placebo to Zometa IV at the 4 week intervals between the q 12 week zoledronic acid infusions in order to maintain the blind.
Placebo / Zoledronic Acid Participants randomized to this arm received placebo but the arm was later dropped and participants in this arm were later switched to the zoledronic acid q 4 weeks according to a study amendment.

Participant Flow:   Overall Study
    Zoledronic Acid Every (q) 4 Weeks     Zoledronic Acid q 12 Weeks     Placebo / Zoledronic Acid  
STARTED     200     203     13  
Treated (Safety Set)     198     202     13  
COMPLETED     106     127     8  
NOT COMPLETED     94     76     5  
Disease progression                 24                 19                 2  
Death                 10                 7                 1  
Administrative problems                 1                 2                 0  
Withdrawal by Subject                 20                 26                 1  
Protocol Violation                 6                 5                 0  
Abnormal test procedure result(s)                 2                 0                 0  
Abnormal laboratory value(s)                 12                 3                 0  
Adverse Event                 18                 14                 1  
Lost to Follow-up                 1                 0                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Zoledronic Acid Every (q) 4 Weeks Participants received 4mg of zoledronic acid intravenously (IV) infusion q 4 weeks.
Zoledronic Acid q 12 Weeks Participants received 4 mg zoledronic acid IV q 12 weeks and received placebo to Zometa IV at the 4 week intervals between the q 12 week zoledronic acid infusions in order to maintain the blind.
Placebo / Zoledronic Acid Participants randomized to this arm received placebo but the arm was later dropped and participants in this arm were later switched to the zoledronic acid q 4 weeks according to a study amendment.
Total Total of all reporting groups

Baseline Measures
    Zoledronic Acid Every (q) 4 Weeks     Zoledronic Acid q 12 Weeks     Placebo / Zoledronic Acid     Total  
Number of Participants  
[units: participants]
  200     203     13     416  
Age  
[units: years]
Mean ± Standard Deviation
  59.2  ± 11.10     58.6  ± 11.15     60.8  ± 12.19     58.9  ± 11.14  
Gender, Customized [1]
[units: participants]
  200     203     13     416  
[1] All participants were female.



  Outcome Measures
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1.  Primary:   Proportion of Patients Who Experienced at Least One Skeletal Related Event (SRE)   [ Time Frame: 52 weeks ]

2.  Secondary:   Time to First SRE   [ Time Frame: 52 weeks ]

3.  Secondary:   Time to First Individual Type of SRE   [ Time Frame: 52 weeks ]

4.  Secondary:   Change From Baseline in Mean Composite Brief Pain Inventory (BPI) Score   [ Time Frame: baseline, 52 weeks ]

5.  Secondary:   Change From Baseline in Mean Analgesic Score   [ Time Frame: baseline, 52 weeks ]

6.  Secondary:   Change From Baseline in Urinary N-telopeptide / Creatinine Ratio   [ Time Frame: baseline, 48 weeks ]

7.  Secondary:   Change From Baseline in Serum Bone Specific Alkaline Phosphatase   [ Time Frame: baseline, 48 weeks ]

8.  Secondary:   Skeletal Morbidity Rate   [ Time Frame: 52 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Study Director
Organization: Novartis
phone: 862-778-8300


No publications provided


Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00320710     History of Changes
Other Study ID Numbers: CZOL446E2352
Study First Received: April 28, 2006
Results First Received: July 8, 2014
Last Updated: August 18, 2014
Health Authority: United States: Food and Drug Administration