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Sponsors and Collaborators: |
James Graham Brown Cancer Center University of Louisville |
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Information provided by: | James Graham Brown Cancer Center |
ClinicalTrials.gov Identifier: | NCT00264082 |
The purpose of this research study is to evaluate the usefulness of the TRAP protein as (1) an early indicator of bone destruction and (2) a tool for assessing the effect of Zometa® in treating symptoms of bone metastases due to breast cancer. Tartrate-resistant acid phosphatase (TRAP) is a protein released into the blood stream as a result of bone destruction caused by metastasis of breast cancer to the bone. Bone destruction causes pain and bone fractures. This study will measure TRAP levels in serum taken from breast cancer patients to see if TRAP levels will be able to predict the effect of Zometa® treatment on bone destruction, pain and bone fractures.
Condition | Intervention | Phase |
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Breast Cancer |
Drug: Zometa(drug) |
Phase II |
Study Type: | Observational |
Study Design: | Screening, Longitudinal, Defined Population, Retrospective/Prospective Study |
Official Title: | “Tartrate-Resistant Acid Phosphatase as a Bone Resorption Marker in Stage IV Breast Cancer Patients With Bone Metastasis During Zometa Treatment: A Pilot Study” |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Inability to provide informed consent
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United States, Kentucky | |
James Graham Brown Cancer Center, 529 S. Jackson St. | |
Louisville, Kentucky, United States, 40202 |
Principal Investigator: | Leela Bhupalam, MD | University of Louisville, James Graham Brown Cancer Center |
Study ID Numbers: | 419.04 |
Study First Received: | December 9, 2005 |
Last Updated: | June 1, 2007 |
ClinicalTrials.gov Identifier: | NCT00264082 |
Health Authority: | United States: Food and Drug Administration |
Zoledronic acid Skin Diseases Musculoskeletal Diseases Bone Resorption |
Neoplasm Metastasis Breast Neoplasms Bone Diseases Breast Diseases |
Neoplastic Processes Neoplasms Pathologic Processes Neoplasms by Site |