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NCT00765687 Clinical Trial

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

Non-small Cell Lung Cancer Clinical Trial

— BLEST  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00765687
Other study ID # CZOL446ECN07
Secondary ID
Status Completed
Phase Phase 4
First received September 29, 2008
Last updated December 8, 2013
Start date August 2008
Est. completion date May 2012

Study information
Verified date December 2011
Source Sun Yat-sen University
Contact n/a
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 432
Est. completion date May 2012
Est. primary completion date May 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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 -

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
China SunYat-senU GuangZhou Guangdong

Sponsors (2)
Lead Sponsor Collaborator
Sun Yat-sen University Novartis

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Skeleton-related event 24 months No
Secondary overall survival 24 months No
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