Zoledronate to Preserve Bone Mineral Density
Name of the Trial
Phase II Randomized Study of the Effect of Zoledronate Versus Observation on Bone Mineral Density of the Lumbar Spine in Patients Undergoing Risk-Reducing Excision of Both Ovaries (GOG-0215). See the protocol summary.
Dr. David Alberts, Dr. Larissa Korde, Dr. Gus Rodriguez, and Ms. Lisa Hess, Gynecologic Oncology Group.
Why This Trial Is Important
Women whose family history or genetic make-up put them at high risk of ovarian cancer may choose to have their ovaries removed as a preventive measure. This surgery, however, can lead to early and accelerated bone loss in premenopausal women. The ovaries produce estrogen, a hormone that normally helps prevent bone loss.
Drugs called bisphosphonates have been shown to reduce the bone loss caused by menopause and some other medical conditions. Now doctors want to know if a bisphosphonate called zoledronate (Zometa®) can help prevent bone loss in premenopausal women undergoing risk-reducing surgery to remove both ovaries.
In this trial, all women will have their bone mineral density checked prior to surgery and receive calcium and vitamin D supplements for 18 months following surgery. In addition, half of the women will be randomly assigned to receive intravenous zoledronate once every 6 months. The remaining women will be monitored without receiving additional treatment. Bone mineral density will be checked at 9 months and 18 months following surgery.
"Premenopausal women undergoing risk-reducing surgery typically are not monitored adequately for osteoporosis, but it is a very serious side effect for these women," said Dr. Alberts. "All women in this trial will benefit from very close observation, and those receiving zoledronate will be getting a drug with a record of preventing and reversing bone loss in cancer patients."
Who Can Join This Trial
Researchers will enroll 222 premenopausal women at increased risk of ovarian cancer who are undergoing surgery to remove both ovaries. See the list of eligibility criteria.
Study Sites and Contact Information
Study sites in the United States are recruiting patients for this trial. See the list of study contacts or call the NCI's Cancer Information Service at 1-800-4-CANCER (1-800-422-6237) for more information. The toll-free call is confidential.