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

DISEASE CHARACTERISTICS:

• 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

PATIENT CHARACTERISTICS:

• Premenopausal*

  • Last menstrual cycle occurred < 12 months prior to study enrollment NOTE: *In unclear cases premenopausal status may be determined by follicle stimulating hormone level AND must be ≤ 20 U/L
• 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

PRIOR CONCURRENT THERAPY:

• 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