What is this clinical trial all about?

Clinical trials are research studies in which people help doctors find ways to improve health. Each study tries to answer scientific questions and to find better ways to prevent, diagnose or treat diseases and their side effects. 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 the ovaries.

Women who choose to have surgical removal of their ovaries are invited to join this study. Removal of the ovaries in women who are still having menstrual periods results in periods stopping earlier than they normally would, also called premature menopause. The ovaries produce estrogen, which helps to maintain bone mineral density, or bone strength. Low bone mineral density is also called osteoporosis. Women who undergo premature menopause are at increased risk for osteoporosis.

Zometa® is in class of drugs called bisphosphonates, which are often used in for prevention and treatment of osteoporosis. Zometa is also used in the treatment of bone disease and high blood calcium levels associated with some cancers. It is given as an intravenous (IV) infusion.

What will happen in this study?

Participants may enroll in the study prior to, or up to 8 weeks after having surgery to remove their ovaries. If you participate in this study, you will be “randomized” into one of the study groups described below. Randomization means that you are put into a group by chance. A computer picks which group you will be in. You will have an equal chance of being placed in either group. Neither you, your doctor, nor the researchers will be able to choose which group you are in.

• Treatment Group: If you are assigned to the treatment group, you will receive an injection of zoledronic acid (Zometa®) every six months for a total of three treatments. The first injection will be given two to three months after you undergo surgical removal of both ovaries. Zoledronic acid is given as an injection into your vein over about 15 minutes. You will also be asked to give blood samples, undergo a bone density test, and complete questionnaires at the time of enrollment and periodically throughout the 18 month study period.
  
  
• Observation Group: If you are assigned to the observation group, you will not receive Zometa, but will be asked to give blood samples, undergo a bone density test, and complete questionnaires at the time of enrollment and periodically throughout the 18 month study period. Participants in both the Treatment Group and the Observation Group will be asked to take daily calcium and vitamin D supplements by mouth, to engage in regular, weight-bearing exercise, and to avoid tobacco smoking. This is the current recommended treatment approach for women who are at increased risk of osteoporosis.