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