Trial Search Results

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

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Gynecologic Oncology Group

Collaborator: National Cancer Institute (NCI)

Stanford Investigator(s):


  • Other: Laboratory Biomarker Analysis
  • Drug: Zoledronic Acid


Phase 2


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

      - 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

   - 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

   - 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

         - 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

   - 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

Ages Eligible for Study

N/A - N/A

Genders Eligible for Study


Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cancer Clinical Trials Office
Not Recruiting