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