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

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ClinicalTrials.gov Identifier: NCT00697619
Recruitment Status : Completed
First Posted : June 16, 2008
Results First Posted : March 2, 2012
Last Update Posted : March 7, 2012
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Li Zhang, Sun Yat-sen University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Nasopharyngeal Cancer
Intervention Drug: Zometa (zoledronic acid)
Enrollment 60
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Test Group Control Group
Hide Arm/Group Description 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. Anti-neoplastic therapy alone. Patients can receive concomitant cycles of chemotherapy or radiotherapy.
Period Title: Overall Study
Started 30 30
Completed 24 22
Not Completed 6 8
Reason Not Completed
Lack of Efficacy             2             2
Adverse Event             4             6
Arm/Group Title Test Group Control Group Total
Hide Arm/Group Description 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. Anti-neoplastic therapy alone. Patients can receive concomitant cycles of chemotherapy or radiotherapy. Total of all reporting groups
Overall Number of Baseline Participants 30 30 60
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 60 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
30
 100.0%
29
  96.7%
59
  98.3%
>=65 years
0
   0.0%
1
   3.3%
1
   1.7%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants 30 participants 60 participants
46  (10) 41  (11) 44  (11)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 60 participants
Female
5
  16.7%
3
  10.0%
8
  13.3%
Male
25
  83.3%
27
  90.0%
52
  86.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
China Number Analyzed 30 participants 30 participants 60 participants
30 30 60
1.Primary Outcome
Title Comparing the Level of Urinary N-telopeptide (uNTx) in the Two Arms .
Hide Description [Not Specified]
Time Frame Baseline, the first, second and third month
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Test Group Control Group
Hide Arm/Group Description:
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.
Anti-neoplastic therapy alone. Patients can receive concomitant cycles of chemotherapy or radiotherapy.
Overall Number of Participants Analyzed 30 29
Median (Standard Error)
Unit of Measure: nM /mM
Baseline 75  (15) 94  (16)
the first month 29  (12) 88  (23)
the second month 17  (7) 52  (21)
the third month 11  (20) 45  (27)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Test Group, Control Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.370
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Test Group, Control Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Test Group, Control Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Test Group Control Group
Hide Arm/Group Description 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. Anti-neoplastic therapy alone. Patients can receive concomitant cycles of chemotherapy or radiotherapy.
All-Cause Mortality
Test Group Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Test Group Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   15/30 (50.00%)   17/29 (58.62%) 
Blood and lymphatic system disorders     
Leukopenia  13/30 (43.33%)  13/29 (44.83%) 
Neutropenia  8/30 (26.67%)  7/29 (24.14%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Test Group Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   15/30 (50.00%)   16/29 (55.17%) 
General disorders     
bone pain, nausea, anemia, vomiting,constipation, dyspnea and fatigue  15/30 (50.00%)  16/29 (55.17%) 
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)
Responsible Party: Li Zhang, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT00697619     History of Changes
Other Study ID Numbers: CZOL446ECN02
First Submitted: June 11, 2008
First Posted: June 16, 2008
Results First Submitted: December 19, 2011
Results First Posted: March 2, 2012
Last Update Posted: March 7, 2012