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A Study of Zoledronic Acid in the Prevention of Cancer Therapy-induced Bone Loss

This study has been terminated.
(Due to rare patient population, planned number of patients could not be recruited in a reasonable timeframe. Recruitment was stopped prematurely.)
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00333229
First received: May 31, 2006
Last updated: November 17, 2014
Last verified: November 2014
Results First Received: November 17, 2014  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Primary Hormone Receptor Negative Breast Cancer in Premenopausal Women
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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Zoledronic Acid Patients randomized into the Zometa arm received a total of 8 study drug infusions which were applied every 3 months. Patients received treatment for 24 months every 3 months.
Placebo Patients randomized into the Placebo Arm received a total of 8 placebo infusions which were applied every 3 months. Patients received treatment for 24 months every 3 months.

Participant Flow:   Overall Study
    Zoledronic Acid     Placebo  
STARTED     6     5  
COMPLETED     6     4  
NOT COMPLETED     0     1  
Lack of Efficacy                 0                 1  



  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 Patients randomized into the Zometa arm received a total of 8 study drug infusions which were applied every 3 months. Patients received treatment for 24 months every 3 months.
Placebo Patients randomized into the Placebo Arm received a total of 8 placebo infusions which were applied every 3 months. Patients received treatment for 24 months every 3 months.
Total Total of all reporting groups

Baseline Measures
    Zoledronic Acid     Placebo     Total  
Number of Participants  
[units: participants]
  6     5     11  
Age  
[units: Years]
Mean ± Standard Deviation
  41.2  ± 6.2     43.2  ± 2.6     42.1  ± 4.8  
Gender  
[units: Participants]
     
Female     6     5     11  
Male     0     0     0  



  Outcome Measures
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1.  Primary:   Change in Bone Mineral Density (BMD) Measured by DXA at Lumbar Spine (L2-L4) Between Baseline and 24 Months.   [ Time Frame: 24 months ]

2.  Secondary:   Bone Mineral Density (BMD) Measured by QUS at os Calcis and Phalanges After 24 Months   [ Time Frame: 2 years ]

3.  Secondary:   Course of Biochemical Markers of Bone Turn Over (FSH, Estradiol (E2), Osteocalcin, PINP, Procollagene-I-peptid, Deoxypyridinoline in Serum)   [ Time Frame: 2 years ]

4.  Secondary:   Pathologic Fractures During 24 Month   [ Time Frame: 2 years ]

5.  Secondary:   Development of Metastases as Assessed by X-ray, CT, or MRI During 24 Months and During 60 Months   [ Time Frame: 2 years ]


  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 Pharmaceuticals
phone: 862-778-8300


No publications provided


Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00333229     History of Changes
Other Study ID Numbers: CZOL446GDE13, 2004-002831-14
Study First Received: May 31, 2006
Results First Received: November 17, 2014
Last Updated: November 17, 2014
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices