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Screening Non Small Cell Lung Cancer With Bone Metastasis and Efficacy and Safety Research of Receiving Bisphosphonates (BLEST)

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: NCT00765687
Recruitment Status : Completed
First Posted : October 3, 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 screening methods, parameter of NTX and the efficacy and safety of zoledronic acid treatment in addition to anti-tumor therapy in patients of non-small cell cancer with bone metastasis in china.

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Bone Metastases Drug: bisphosphates Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 432 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Multi-center Observational Clinical Study of Screening of Non-small-cell Lung Cancer With Bone Metastasis and Efficacy and Safety of Those Receiving Bisphosphonates
Study Start Date : August 2008
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
No Intervention: Observation Drug: bisphosphates
any bisphosphate, repeated every 4 weeks for up to 24 months. Co-administration with Zometa: Calcium 500 mg + vitamin D 400-500 IU daily

Primary Outcome Measures :
  1. Skeleton-related event [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. overall survival [ Time Frame: 24 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Age >18, either sex
  2. Histologically confirmed non-small cell cancer
  3. One bone metastasis at least confirmed by image(X ray,CT or others)
  4. Without receiving zoledronic acid
  5. Life expectancy > 6 M
  6. ECOG <= 2
  7. Signed ICF

Exclusion Criteria:

  1. Women who are pregnant or in lactation
  2. Patients with hyperostosis
  3. with brain metastasis(exception of those without symptom or with Metastasis Lesions under controlled
  4. Previous or current treatment with any other bisphosphonates, bone- protecting, cytotoxic or targeted therapy
  5. 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): NCT00765687

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China, Guangdong
GuangZhou, Guangdong, China
Sponsors and Collaborators
Sun Yat-sen University
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Principal Investigator: Zhang Li, Master Cancer Center of Sun Yat-Sen University (CCSU)
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Responsible Party: Li Zhang, Profressor, Sun Yat-sen University Identifier: NCT00765687    
Other Study ID Numbers: CZOL446ECN07
First Posted: October 3, 2008    Key Record Dates
Last Update Posted: December 10, 2013
Last Verified: December 2011
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