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NCT00265200 Clinical Trial

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

Metastases Clinical Trial

Official title:
Bone Metabolic Markers, TRAP, and Zometa's Effect on Bone Metastasis Due to Lung Cancer

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00265200
Other study ID # 565.04
Secondary ID BCC-LUN-04-002
Status Terminated
Phase Phase 2
First received December 12, 2005
Last updated March 1, 2018
Start date February 2005
Est. completion date December 2010

Study information
Verified date March 2018
Source University of Louisville
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility
Status Terminated
Enrollment 28
Est. completion date December 2010
Est. primary completion date August 2009
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• zoledronic acid
3.0-4.0 mg by IV (in the vein), once a month for 6 months

Locations
Country Name City State
United States James Graham Brown Cancer Center Louisville Kentucky

Sponsors (3)
Lead Sponsor Collaborator
University of Louisville James Graham Brown Cancer Center, Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Average Percent Change From Baseline in TRAP Levels at 2 Weeks Change was calculated as 100% (value at baseline minus value at 2 weeks)/value at baseline TRAP levels at Baseline and 2 weeks after first Zometa infusion
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