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

Completed · Phase 2

Conditions studied: Hereditary Breast and Ovarian Cancer Syndrome, Osteoporosis, Ovarian Carcinoma

In brief

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.

Key facts

Study ID

NCT00305695

Run by

Gynecologic Oncology Group

People needed

160

Starts

2005-11-28

Last updated by the study team

2020-03-24

Who can join

Age: any. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• Banner University Medical Center - Tucson — Tucson, Arizona, United States
• University of Arizona Cancer Center-North Campus — Tucson, Arizona, United States
• Providence Saint Joseph Medical Center/Disney Family Cancer Center — Burbank, California, United States
• City of Hope Comprehensive Cancer Center — Duarte, California, United States
• Kaiser Permanente Los Angeles Medical Center — Los Angeles, California, United States
• Cedars Sinai Medical Center — Los Angeles, California, United States
• UC Irvine Health/Chao Family Comprehensive Cancer Center — Orange, California, United States
• Stanford Cancer Institute Palo Alto — Palo Alto, California, United States
• University of California Davis Comprehensive Cancer Center — Sacramento, California, United States
• University of California San Diego — San Diego, California, United States
• Colorado Gynecologic Oncology Group — Aurora, Colorado, United States
• Boulder Community Hospital — Boulder, Colorado, United States
• Penrose-Saint Francis Healthcare — Colorado Springs, Colorado, United States
• SCL Health Saint Joseph Hospital — Denver, Colorado, United States
• Rose Medical Center — Denver, Colorado, United States
• North Colorado Medical Center — Greeley, Colorado, United States
• McKee Medical Center — Loveland, Colorado, United States
• North Suburban Medical Center — Thornton, Colorado, United States
• SCL Health Lutheran Medical Center — Wheat Ridge, Colorado, United States
• Hartford Hospital — Hartford, Connecticut, United States
• The Hospital of Central Connecticut — New Britain, Connecticut, United States
• Yale University — New Haven, Connecticut, United States
• Beebe Medical Center — Lewes, Delaware, United States
• Christiana Care Health System-Christiana Hospital — Newark, Delaware, United States
• Mayo Clinic in Arizona — Scottsdale, Arizona, United States

Full record on ClinicalTrials.gov

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