A Phase II Randomized Study of the Effect of Zoledronic Acid Versus Observation on Bone Mineral Density of the Lumbar Spine in Women Who Elect to Undergo Surgery That Results in Removal of Both Ovaries
OBJECTIVES:
Primary
- Compare the effect of zoledronate vs observation on bone loss associated with surgery
(at a minimum, any surgical procedure that results in removal of both ovaries) in
patients undergoing excision of both ovaries.
Secondary
- Compare the change in bone mineral density of the bilateral hip in patients treated
with these regimens.
Tertiary
- Compare the effect of zoledronate vs observation on biochemical markers of bone
resorption and bone formation (N-telopeptide and bone specific alkaline phosphatase)
during 1 year of treatment.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2
treatment arms.
All patients undergo surgery, with removal of both ovaries, in month 1. All patients are
requested to take calcium supplements twice daily and a multivitamin containing vitamin D
once daily beginning in month 1 and continuing for up to 18 months.
- Arm I: Beginning 60-90 days after surgery, patients receive zoledronate IV over 15
minutes once in months 3, 9, and 15.
- Arm II: Patients are observed for 18 months after surgery. In both arms, patients
complete physical activity questionnaires at baseline and in months 3, 9, 15, and 18.
Patients undergo bone mineral density test of lumbar spine and total hip at baseline
and in months 9 and 18. Patients also undergo blood collection at baseline and
periodically during the study for biomarker studies.
PROJECTED ACCRUAL: A total of 222 patients will be accrued for this study.
Observational
N/A
Bone mineral density of the lumbar spine as measured by dual-energy x-ray absorptiometry (DEXA) scan at baseline (may be before surgery) and 9 and 18 months after surgery
No
David S. Alberts, MD
Study Chair
University of Arizona
United States: Federal Government
CDR0000462217
NCT00305695
November 2005
Name | Location |
---|---|
Mayo Clinic Scottsdale | Scottsdale, Arizona 85259 |
Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
Tripler Army Medical Center | Honolulu, Hawaii 96859-5000 |
CCOP - Kansas City | Kansas City, Missouri 64131 |
CCOP - Christiana Care Health Services | Wilmington, Delaware 19899 |
Boulder Community Hospital | Boulder, Colorado 80301-9019 |
Penrose Cancer Center at Penrose Hospital | Colorado Springs, Colorado 80933 |
CCOP - Colorado Cancer Research Program | Denver, Colorado 80224-2522 |
St. Joseph Hospital | Denver, Colorado 80218 |
North Suburban Medical Center | Thornton, Colorado 80229 |
George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus | New Britain, Connecticut 06050 |
West Michigan Cancer Center | Kalamazoo, Michigan 49007-3731 |
Case Comprehensive Cancer Center | Cleveland, Ohio 44106-5065 |
Avera Cancer Institute | Sioux Falls, South Dakota 57105 |
Vanderbilt-Ingram Cancer Center | Nashville, Tennessee 37232-6838 |
Providence Saint Joseph Medical Center - Burbank | Burbank, California 91505 |
Holden Comprehensive Cancer Center at University of Iowa | Iowa City, Iowa 52242-1002 |
Charles M. Barrett Cancer Center at University Hospital | Cincinnati, Ohio 45267-0526 |
CCOP - St. Louis-Cape Girardeau | Saint Louis, Missouri 63141 |
Rebecca and John Moores UCSD Cancer Center | La Jolla, California 92093-0658 |
Fletcher Allen Health Care - University Health Center Campus | Burlington, Vermont 05401 |
Washington Cancer Institute at Washington Hospital Center | Washington, District of Columbia 20010 |
Hulston Cancer Center at Cox Medical Center South | Springfield, Missouri 65807 |
St. John's Regional Health Center | Springfield, Missouri 65804 |
Lake/University Ireland Cancer Center | Mentor, Ohio 44060 |
Women and Infants Hospital of Rhode Island | Providence, Rhode Island 02905 |
Carilion Gynecologic Oncology Associates | Roanoke, Virginia 24014 |
Central Baptist Hospital | Lexington, Kentucky 40503 |
Long Island Jewish Medical Center | New Hyde Park, New York 11040 |
Yale Cancer Center | New Haven, Connecticut 06520-8028 |
St. Vincent Indianapolis Hospital | Indianapolis, Indiana 46260 |
NYU Cancer Institute at New York University Medical Center | New York, New York 10016 |
Mount Sinai Medical Center | New York, New York 10029 |
St. Vincent Hospital Regional Cancer Center | Green Bay, Wisconsin 54307-3508 |
North Colorado Medical Center | Greeley, Colorado 80631 |
McKee Medical Center | Loveland, Colorado 80539 |
David C. Pratt Cancer Center at St. John's Mercy | St. Louis, Missouri 63141 |
Riverside Methodist Hospital Cancer Care | Columbus, Ohio 43214 |
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center | Los Angeles, California 90048-1865 |
Indiana University Melvin and Bren Simon Cancer Center | Indianapolis, Indiana 46202-5289 |
Masonic Cancer Center at University of Minnesota | Minneapolis, Minnesota 55455 |
University of New Mexico Cancer Center | Albuquerque, New Mexico 87131-5636 |
Don Monti Comprehensive Cancer Center at North Shore University Hospital | Manhasset, New York 11030 |
Oklahoma University Cancer Institute | Oklahoma City, Oklahoma 73104 |
Knight Cancer Institute at Oregon Health and Science University | Portland, Oregon 97239-3098 |
Virginia Commonwealth University Massey Cancer Center | Richmond, Virginia 23298-0037 |
University of Virginia Cancer Center | Charlottesville, Virginia 22908 |
Helen and Harry Gray Cancer Center at Hartford Hospital | Hartford, Connecticut 06102-5037 |
Harry & Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center | Baltimore, Maryland 21237 |
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton | Marlton, New Jersey 08053 |
Cancer Care Associates - Saint Francis Campus | Tulsa, Oklahoma 74136-1929 |
Cancer Institute of New Jersey at Cooper - Voorhees | Voorhees, New Jersey 08043 |
Stanford Cancer Center | Stanford, California 94305-5824 |
Tunnell Cancer Center at Beebe Medical Center | Lewes, Delaware 19958 |
Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital | Fort Lauderdale, Florida 33308 |
Evanston Hospital | Evanston, Illinois 60201-1781 |
Union Hospital Cancer Program at Union Hospital | Elkton MD, Maryland 21921 |
Truman Medical Center - Hospital Hill | Kansas City, Missouri 64108 |
Heartland Hematology Oncology Associates, Incorporated | Kansas City, Missouri 64118 |
Monter Cancer Center of the North Shore-LIJ Health System | Lake Success, New York 11042 |
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center | Columbus, Ohio 43210-1240 |
FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center | Pinehurst, North Carolina 28374 |
Louisville Oncology at Norton Cancer Institute - Louisville | Louisville, Kentucky 40202 |
Good Samaritan Hospital Cancer Treatment Center | Cincinnati, Ohio 45220 |
Renown Institute for Cancer at Renown Regional Medical Center | Reno, Nevada 89502 |
Central Dupage Cancer Center | Warrenville, Illinois 60555 |
Arizona Cancer Center at University Medical Center North | Tucson, Arizona 85719 |