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Efficacy and Safety Study of ZOMETA® in Treatment of High-level NTX Non Small Cell Lung Cancer With Bone Metastasis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00762346
Recruitment Status : Completed
First Posted : September 30, 2008
Last Update Posted : December 10, 2013
Information provided by (Responsible Party):
Li Zhang, Sun Yat-sen University

Brief Summary:
A multicenter prospective study to assess the efficacy and safety of ZOMETA® in treatment of high-level NTX non small cell lung cancer with bone metastasis.

Condition or disease Intervention/treatment Phase
Non Small Cell Lung Cancer Bone Metastases High NTX Level Drug: zometa Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 156 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety Study of ZOMETA® in Treatment of High-level NTX Non Small Cell Lung Cancer With Bone Metastasis
Study Start Date : September 2008
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1 Drug: zometa
zometa 4mg i.v. every 4 weeks for up to 2 years

Primary Outcome Measures :
  1. Skeleton-related event [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. OS [ Time Frame: 2 years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age > 18
  • Histologically confirmed non-small cell cancer
  • One bone metastasis at least confirmed by image(X ray, CT or others)
  • NTX > 50nM BCE/mM creatinine
  • Life expectancy > 6 M
  • ECOG <= 2
  • Signed ICF

Exclusion Criteria:

  • Women who are pregnant or in lactation
  • Patients with hyperostosis with brain metastasis(exception of those without symptom or with Metastasis Lesions under controlled
  • Previous or current treatment with any other bisphosphonates, bone- protecting, cytotoxic or targeted therapy
  • Severe co-morbidity of any type that may interfere with assessment of the patient for the study -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00762346

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China, Guangdong
cancer center, Sun Yat-sen University
Guangzhou, Guangdong, China, 510080
Sponsors and Collaborators
Sun Yat-sen University
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Principal Investigator: Li Zhang, MD Sun Yat-sen University
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Responsible Party: Li Zhang, Profressor, Sun Yat-sen University Identifier: NCT00762346    
Other Study ID Numbers: CZOL446ECN06T
First Posted: September 30, 2008    Key Record Dates
Last Update Posted: December 10, 2013
Last Verified: December 2011
Keywords provided by Li Zhang, Sun Yat-sen University:
non small cell lung cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Neoplasm Metastasis
Bone Neoplasms
Bone Marrow Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Neoplastic Processes
Pathologic Processes
Bone Diseases
Musculoskeletal Diseases
Hematologic Diseases
Zoledronic Acid
Bone Density Conservation Agents
Physiological Effects of Drugs