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Trial Information
Summary: Women who plan to have their ovaries removed sought for research study.
The Cancer Center at UVa Health System seeks for a research study women who have chosen to undergo surgery that has resulted in the removal of both ovaries.
The purpose of this study is to find out what effects zoledronic acid (Zometa) has on preventing bone loss in women who go through early menopause due to removal of their ovaries. Zometa has been approved by the FDA for treating certain bone and blood cancers, but it is considered experimental for this study as it is not approved by the FDA for treating bone loss.
If you should decide to participate in the study, you will undergo physical exams, blood tests, DEXA scans (an xray test that measures bone density), and questionnaires. You will need to come for 5 study visit. Each visit will last about 2 hours. After your 18-month visit, there will be no futher visits for the study. Participation in the study will last 18 months from the time surgery is scheduled. You will randomly be assigned into one of two groups. If you are assigned to the first group, you will receive an intravenous infusion of Zometa once every six months for a total of 3 doses. You will also be given information about how to maintain bone health through exercise, healthy eating and vitamin supplements. If you are assigned to the second group, you will not receive the study drug but you will receive information about how to maintain bone health through exercise, healthy eating, and vitamin supplements.
There is no compensation available for participants in this study.
Contact Information: For more information please contact: Heather Lothamer, MSN Phone: 434-924-2745 Email: hll5y@virginia.edu IRB-HSR #13230 Principal Investigator: Susan Modesitt, MD
www.healthsystem.virginia.edu/clinical_trials
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Contact:
Heather Lothamer BS,BSN,MSN
University of Virginia
School of Medicine Gynecologic Oncology, Obstetrics & Gynecology
Charlottesville, VA 22908
Telephone: 434-924-2745
Fax: 434-982-3509
Email:
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If you would like to learn more about participating in this study, please send an e-mail message using the form below.
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Trial listings updated: November 17, 2008 at 2:53:09 PM
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