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

History of Changes

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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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 ]

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Serious Adverse Events

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Other Adverse Events

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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.

Limitations and Caveats

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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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

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