Using TRAP to Evaluate the Effect of Zometa on Bone Metastasis Due to Lung Cancer

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-02-28

Study Completion Date

2010-12-31

Brief Summary

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The purpose of this study is to evaluate a new blood test as a way to follow the effect of Zometa in treating bone metastases due to lung cancer.

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Detailed Description

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The purpose of this research study is to evaluate a new blood test as a way to follow the effect of Zometa in treating bone metastases. The blood test will look for a protein, called TRAP, which is released into the blood stream by the breakdown of bone. This study will compare the TRAP blood test with other blood tests for bone destruction.

Conditions

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Carcinoma, Non-Small Cell Lung Carcinoma, Small Cell Lung Metastases

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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zoledronic acid

3.0-4.0 mg by IV (in the vein), once a month for 6 months

Group Type EXPERIMENTAL

zoledronic acid

Intervention Type DRUG

3.0-4.0 mg by IV (in the vein), once a month for 6 months

Interventions

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zoledronic acid

3.0-4.0 mg by IV (in the vein), once a month for 6 months

Intervention Type DRUG

Other Intervention Names

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Zometa

Eligibility Criteria

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Inclusion Criteria

* invasive lung cancer (small cell or non-small cell lung cancer)
* osteolytic bone metastasis determined by clinical exam, bone scan/XR
* age \> 18 years

Exclusion Criteria

* concurrent malignancy with a second primary
* renal failure (serum creatinine \> 3mg/dl)
* pregnancy
* active rheumatoid arthritis
* intolerance to zoledronic acid

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No