Trial Information

Summary: A Phase II Randomized Study of the Effect of Zoledronic Acid Versus Observation on Bone Mineral Density of the Lumbar Spine in Woman who Elect to Undergo Risk-Reducing Surgery that Results in Removal of Both Ovaries [GOG0215]

This study is for women who are at increased risk of ovarian cancer and have already decided to have surgery to remove their ovaries [Risk Reducing Salpingo-Oophorectomy (RRSO)]. 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. This study is being conducted to find a way to prevent the loss of bone in women who have chosen to undergo this surgery.
Study participants will have an equal chance of being placed into one of two groups:
1. Group 1 will receive Zometa
2. Group 2 will not receive Zometa
Study participation will last about 18 months (1 1/2 years) from the time the surgery is scheduled.

No Compensation Provided

Patient Inclusion/Exclusion Criteria:

You may be eligible for participation if you:
1. are 30 years old or older
2. are at increased genetic risk of ovarian cancer and have elected to have the RRSO procedure

You may not be eligible for participation if you:
1. are pregnant or breastfeeding
2. have already had the RRSO procedure
3. have no prior history of ovarian cancer
4. have HIV
5. have had recent (within 6 weeks) or planned dental or jaw surgery

If you would like to learn more about participating in this study, please send an e-mail message using the form below.