NCT00765687
Completed
Phase 4
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
Sun Yat-sen University1 site in 1 country432 target enrollmentAugust 2008
Overview
- Phase
- Phase 4
- Intervention
- bisphosphates
- Conditions
- Non-small Cell Lung Cancer
- Sponsor
- Sun Yat-sen University
- Enrollment
- 432
- Locations
- 1
- Primary Endpoint
- Skeleton-related event
- Status
- Completed
- Last Updated
- 12 years ago
Overview
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.
Investigators
Li Zhang
Profressor
Sun Yat-sen University
Eligibility Criteria
Inclusion Criteria
- •Age \>18, either sex
- •Histologically confirmed non-small cell cancer
- •One bone metastasis at least confirmed by image(X ray,CT or others)
- •Without receiving zoledronic acid
- •Life expectancy \> 6 M
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 -
Arms & Interventions
Observation
Intervention: bisphosphates
Outcomes
Primary Outcomes
Skeleton-related event
Time Frame: 24 months
Secondary Outcomes
- overall survival(24 months)
Study Sites (1)
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