IRB Number:

06-009046

Trial Status:

Open for Enrollment

Phase: II

Why is this study being done?

The purpose of this study is to look at the effects of zoledronic acid (Zometa) on preventing bone loss in women who undergo early menopause due to surgical removal of their ovaries. Women who choose to have their ovaries removed before menopause will experience immediate menopause due to the loss of estrogen in the body. A lack of estrogen can cause a variety of side effects, one of which is bone loss. Substantial bone loss can lead to a higher risk of bone fractures. This study is being conducted to find a way to prevent the loss of bone in women who have chosen to undergo this surgery.

Who is Eligible to Participate in the Study?

-Women at high risk of developing ovarian cancer who have had their ovaries removed to prevent ovarian cancer.

*More specific, detailed eligibility and/ or exclusion criteria are associated with this trial.

What is Involved With this Study?

If agreeing to be in the study, patients will be asked to participate in the following:
- History and Complete Physical
- Blood Tests
- DEXA Scan This is an x-ray test that measures bone mineral density. The DEXA scan is done at the initial visit and will be repeated at the nine-month and 18-month follow-up visits.
- Urine Pregnancy Test (for patients who are able to get pregnant). This will be done prior to the first DEXA scan.

If patients have had some of the tests recently, they may not need to be repeated. This will be up to the study doctor.

During the study:
After the patient's surgery they will be put in one of two groups by chance, (as in the flip of a coin). A computer program will assign the patient to one of the study groups. Neither the patient nor their doctor can choose the group the patient will be in. The patient will have equal chance of being placed in either group.

If in Group 1, the patient will be given a 4 mg infusion of zometa through a tube attached to a needle into the vein (intravenously). This infusion will be given over a period of 15-20 minutes. This infusion will be given once every six months for a total of three doses. The treatment will be given at Month 3, 9 and 15. Patients will also be given
information about how to maintain bone health through exercise, healthy eating, and oral calcium and vitamin D supplements.

If in Group 2, the patient will not receive study medication but will be given information about how to maintain bone health through exercise, healthy eating and oral calcium and vitamin D supplements.

All tests and procedures will be done in an outpatient setting.

How long will the Study run?

Patients will be asked to participate in this study for approximately 18 months from the time their surgery is scheduled.

Sponsor(s): Gynecologic Oncology Group (COG)

Study Activation/Registration Date: 10/12/2007

IRB Review and Approval Date: 06/27/2007

Study Type: Treatment

Projected Accrual: The plan is to have up to 222 patients participate from multiple medical centers.

Costs of Study:There may be standard patient care costs related to participating in a cancer research study.

Principal Investigator: P. Haluska Jr., MD

Who can I Contact for Additional Information on this Trial?

Complete Request Form for Cancer Clinical Trial Information at Mayo Clinic or
For more information about this study or other clinical trial options, please contact our Mayo Clinic Cancer Center Clinical Trials Referral Office.

• Patients living within the United States, call 507-538-7623, or e-mail cancerclinicaltrials@mayo.edu


• Patients living outside the United States may call our International Office at 507-284-8884, or e-mail intl.mcr@mayo.edu.

What is/are the Locations of this Clinical Trial?

• Rochester, MN

Last updated: 06/10/2008