To Evaluate the Efficacy of ZOMETA® in Treatment of Bone Metastases in Patients With Stage IV Nasopharyngeal Cancer

This study has been completed.
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Li Zhang, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT00697619
First received: June 11, 2008
Last updated: March 4, 2012
Last verified: December 2011
Results First Received: December 19, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Nasopharyngeal Cancer
Intervention: Drug: Zometa (zoledronic acid)

  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
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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
Test Group Zometa (zoledronic acid) 4 mg over 15 min IV infusion, every 4 week Anti-neoplastic therapy .Patients can receive concomitant cycles of chemotherapy or radiotherapy.
Control Group Anti-neoplastic therapy alone. Patients can receive concomitant cycles of chemotherapy or radiotherapy.

Participant Flow:   Overall Study
    Test Group     Control Group  
STARTED     30     30  
COMPLETED     24     22  
NOT COMPLETED     6     8  
Lack of Efficacy                 2                 2  
Adverse Event                 4                 6  



  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
Test Group Zometa (zoledronic acid) 4 mg over 15 min IV infusion, every 4 week Anti-neoplastic therapy .Patients can receive concomitant cycles of chemotherapy or radiotherapy.
Control Group Anti-neoplastic therapy alone. Patients can receive concomitant cycles of chemotherapy or radiotherapy.
Total Total of all reporting groups

Baseline Measures
    Test Group     Control Group     Total  
Number of Participants  
[units: participants]
  30     30     60  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     30     29     59  
>=65 years     0     1     1  
Age  
[units: years]
Mean ± Standard Deviation
  46  ± 10     41  ± 11     44  ± 11  
Gender  
[units: participants]
     
Female     5     3     8  
Male     25     27     52  
Region of Enrollment  
[units: participants]
     
China     30     30     60  



  Outcome Measures

1.  Primary:   Comparing the Level of Urinary N-telopeptide (uNTx) in the Two Arms .   [ Time Frame: Baseline, the first, second and third month ]


  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 NOT 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.


Results Point of Contact:  
Name/Title: Dr. Li Zhang
Organization: Sun Yat-sen University Cancer Centre
phone: 86-20-87343458(O)
e-mail: zhangli6@mail.sysu.edu.cn


No publications provided


Responsible Party: Li Zhang, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT00697619     History of Changes
Other Study ID Numbers: CZOL446ECN02
Study First Received: June 11, 2008
Results First Received: December 19, 2011
Last Updated: March 4, 2012
Health Authority: China: Food and Drug Administration