Zoledronate or Observation in Maintaining Bone Mineral Density in Patients Who Are Undergoing Surgery to Remove Both Ovaries

Inclusion Criteria: Patients who have elected to undergo, or who have undergone (within 8 weeks) a surgical procedure that results (at minimum) in the absence of both ovaries Patients enrolled in the screening arm of GOG-0199 who decide to undergo surgery are potentially eligible for GOG-0215 Baseline bone mass density (BMD) T-Score ? -1.5 (no more than 1.5 standard deviation below the mean value for young adults) on both the total lumbar spine (L1-L4 region, not individual bones) and bilateral hip Patients who had/have at least 1 intact ovary at the time of surgery are eligible No prior distant metastatic malignant disease within the past 5 years Patients treated for stage M1 (any T, any N) diagnosis in the past 5 years are ineligible Patients who achieved a complete response after treatment for rM0 (any T, any N) within the past 5 years are eligible Premenopausal* Last menstrual cycle occurred < 12 months prior to study enrollment GOG performance status 0-2 Creatinine clearance > 60 mL/min No clinical or radiological evidence of existing fracture of the lumbar spine or bilateral hip No history of hip of spine fracture with low-intensity trauma or not associated with trauma No uncontrolled seizure disorder associated with falls No diseases that influence bone metabolism, including any of the following: Paget?s disease Osteogenesis imperfecta Uncontrolled thyroid or parathyroid dysfunction within 12 months prior to study entry No other nonmalignant systemic disease, including any of the following: Uncontrolled infection Uncontrolled type 2 diabetes mellitus Cardiovascular, renal, hepatic, or lung disease that would prevent prolonged follow-up History of thrombosis or thromboembolism allowed No known HIV positivity No known hypersensitivity to zoledronate or other bisphosphonates No psychiatric, psychological, or other conditions that prevent fully informed consent No other active malignancy except nonmelanoma skin cancer No history of any medical condition that places the patient at risk for donating blood for research purposes (e.g., chronic infectious diseases, sever anemia, or hemophilia) Not pregnant Negative pregnancy test No current active dental problems, including any of the following: Infection of the teeth or jawbone (maxilla or mandible) Dental or fixture trauma Current or prior diagnosis of osteonecrosis of the jaw Exposed bone in the mouth Slow healing after dental procedures No recent (within 6 weeks) or planned dental or jaw surgery (e.g., extraction or implants) No prior treatment for osteoporosis No adjuvant radiotherapy within the past 31 days No chemotherapy within the past 30 days No prior surgery to the hip or spine No prior systemic sodium fluoride for > 3 months during the past 2 years No more than 30 days use in the past 12 months and no concurrent tamoxifen, raloxifene, or any other selective estrogen-receptor modulator (SERM) More than 12 months since prior and no concurrent endocrine therapy Insulin and/or oral antidiabetic medications allowed Thyroid hormone replacement allowed More than 12 months since prior and no concurrent estrogen or hormone replacement therapy (estrogen plus progesterone or estrogen alone) Prior or concurrent oral contraceptives allowed Systemic (oral) hormone replacement therapy following surgery not allowed Vaginal (non-systemic) estrogen allowed More than 12 months since prior and no concurrent oral or IV bisphosphonate More than 12 months since prior and no concurrent anabolic steroids or growth hormone More than 12 months since prior and no concurrent systemic corticosteroids Concurrent short term corticosteroid therapy (to prevent/treat chemotherapy-induced nausea/vomiting) allowed More than 6 months since prior and no concurrent Tibolone More than 2 weeks since prior and no concurrent drugs known to affect the skeleton (e.g., calcitonin, mithramycin, or gallium nitrate) No concurrent chemotherapy or radiotherapy No concurrent aromatase inhibitors Concurrent enrollment on protocol GOG-0199 allowed