Assessment of Tartrate-Resistant Acid Phosphatase (TRAP) as a Bone Resorption Marker in Stage IV Breast Cancer Patients With Bone Metastasis
NCT ID: NCT00264082
Last Updated: 2017-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
30 participants
OBSERVATIONAL
2004-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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OTHER
Interventions
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Zometa(drug)
Eligibility Criteria
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Inclusion Criteria
2. Stage IV Breast Cancer Patients with bone metastasis for whom Zometa treatment will be initiated.
3. Age \> 18
4. Written informed consent prior to study entry
5. Patients may be currently receiving hormone therapy, chemotherapy and/or radiation therapy to the primary tumor.
6. Life expectancy of at least 6 months.
7. We will include patients who have had previous or current radiation therapy to breast
Exclusion Criteria
2. Stage I, Stage II and Stage III
3. ECOG Performance Status 3 or 4.
4. Renal Failure - serum creatinine \>2.O mg/dL at screening
5. AST or ALT \> ULN X 3. at screening
6. Bilirubin \> 3.0 mg/dL at screening
7. Pregnant women
8. Prior or current bisphosphonate therapy
9. Any skeletal related event due to malignancy prior to study enrollment.
10. Patients with osteoporotic fractures prior to study enrollment.
11. Allergy to bisphosphonates
12. Any radiation therapy for the treatment of bone metastases \<4 weeks prior to study start.
13. Any chronic medical condition which would preclude performance or adherence to protocol requirements
14. Inability to provide informed consent
\-
18 Years
FEMALE
No
Sponsors
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James Graham Brown Cancer Center
OTHER
University of Louisville
OTHER
Responsible Party
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Principal Investigators
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Leela Bhupalam, MD
Role: PRINCIPAL_INVESTIGATOR
University of Louisville, James Graham Brown Cancer Center
Locations
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James Graham Brown Cancer Center, 529 S. Jackson St.
Louisville, Kentucky, United States
Countries
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Related Links
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Related Info
Other Identifiers
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419.04
Identifier Type: -
Identifier Source: org_study_id