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

Sun Yat-sen University432 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

432

Conditions

Non-small Cell Lung Cancer Bone Metastases

Interventions

bisphosphatesDRUG

any bisphosphate, repeated every 4 weeks for up to 24 months. Co-administration with Zometa: Calcium 500 mg + vitamin D 400-500 IU daily

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 -

Locations (1)

SunYat-senU

Guangzhou, Guangdong, China

Outcomes

Primary Outcomes

Skeleton-related event

Time frame: 24 months

Secondary Outcomes

overall survival

Time frame: 24 months

Data from ClinicalTrials.gov

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