Zoledronate or Observation in Maintaining Bone Mineral Density in Patients Who Are Undergoing Surgery to Remove Both Ovaries
Condition: Hereditary Breast and Ovarian Cancer Syndrome; Osteoporosis; Ovarian Carcinoma
MeSH terms: Hereditary Breast and Ovarian Cancer Syndrome; Osteoporosis
Intervention: Laboratory Biomarker Analysis; Zoledronic Acid
Intervention description: Correlative studies; Given IV
Intervention MeSH terms: Zoledronic Acid; Imidazole
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 160.0
Sex: Female
Healthy volunteers: No

Summary:

      This randomized phase II trial is studying zoledronate to see how well it works compared to
      observation in maintaining bone mineral density in patients who are undergoing surgery to
      remove both ovaries. Zoledronate may prevent bone loss in patients who are undergoing surgery
      to remove the ovaries.
    

Eligibility criteria:

        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