A Phase II Randomized Study of the Effect of Zeledronic Acid Versus Observation on Bone Mineral Density of the Lumbar Spine in Women Who Elect to Undergo Surgery that Results in Removal of Both Ovaries

IRB-HSR# 13230
Service: Cancer, Women's Health | Category: Cancer (Oncology), Obstetrics/Gynecology
Adult Enrollment: Yes | Minor Enrollment: No
Primary Investigator: Susan Modesitt, M.D.

Contact Information

Contact: Heather Lothamer, M.S.N.
Phone: 434.243.0315
E-mail: hll5y@virginia.edu

Clinical Trial Description

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.

Compensation

There is no compensation available for participants in this study.