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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00765687
Acronym
BLEST
Enrollment
432
Registered
2008-10-03
Start date
2008-08-31
Completion date
2012-05-31
Last updated
2013-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone Metastases, Non-small Cell Lung Cancer

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.

Interventions

DRUGbisphosphates

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

Sponsors

Novartis
CollaboratorINDUSTRY
Sun Yat-sen University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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 -

Design outcomes

Primary

MeasureTime frame
Skeleton-related event24 months

Secondary

MeasureTime frame
overall survival24 months

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026