Zoledronate or Observation in Maintaining Bone Mineral Density in Patients Who Are Undergoing Surgery to Remove Both Ovaries
A total of 222 patients will be accrued for this study.
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
Bone mineral density of the total hip as measured by DEXA scan at baseline (may be before surgery) and 9 and 18 months after surgery
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.
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.
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U.S.A. |
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California |
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Burbank |
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| Providence Saint Joseph Medical Center - Burbank |
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| Clinical Trials Office - Providence Saint Joseph Medical Center - Burbank | |
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Los Angeles |
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| Kaiser Permanente Medical Center - Los Angeles |
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| Scott Lentz, MD | |
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Stanford |
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| Stanford Cancer Center |
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| Clinical Trials Office - Stanford Cancer Center | |
| Email:
cctoffice@stanford.edu |
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Colorado |
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Aurora |
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| Colorado Gynecologic Oncology Group, PC |
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| Susan Davidson, MD | |
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Boulder |
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| Boulder Community Hospital |
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| Clinical Trials Office - Boulder Community Hospital | |
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Denver |
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| CCOP - Colorado Cancer Research Program |
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| Eduardo Pajon, MD | |
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| Rose Medical Center |
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| Eduardo Pajon, MD | |
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Loveland |
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| McKee Medical Center |
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| Eduardo Pajon, MD | |
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Thornton |
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| North Suburban Medical Center |
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| Eduardo Pajon, MD | |
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Wheat Ridge |
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| Exempla Lutheran Medical Center |
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| Clinical Trials Office - Exempla Lutheran Medical Center | |
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Connecticut |
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New Britain |
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| George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus |
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| Clinical Trials Office - George Bray Cancer Center | |
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New Haven |
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| Yale Cancer Center |
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| Clinical Trials Office - Yale Cancer Center | |
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Delaware |
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Lewes |
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| Tunnell Cancer Center at Beebe Medical Center |
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| Clinical Trials Office - Tunnell Cancer Center | |
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|
Newark |
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| CCOP - Christiana Care Health Services |
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| Clinical Trial Office - CCOP - Christiana Care Health Services | |
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Florida |
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Fort Lauderdale |
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|
| Michael and Dianne Bienes Comprehensive Cancer Center
at Holy Cross Hospital |
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| Clinical Trials Office - Michael and Dianne Bienes Comprehensive Cancer Center | |
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|
Jupiter |
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| Ella Milbank Foshay Cancer Center at Jupiter Medical Center |
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| Clinical Trials Office - Ella Milbank Foshay Cancer Center | |
|
|
Orlando |
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| M.D. Anderson Cancer Center at Orlando |
|
| Alan Gordon | Ph: | 407-648-3800 | | 800-648-3818 |
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|
Hawaii |
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Honolulu |
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|
| Tripler Army Medical Center |
|
| Bradford Whitcomb | |
|
Illinois |
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Chicago |
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| University of Illinois Cancer Center |
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| Clinical Trial Office - University of Illinois Cancer Center | |
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|
Evanston |
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| Evanston Northwestern Healthcare - Evanston Hospital |
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| Clinical Trials Office - Evanston Northwestern Healthcare - Evanston Hospital | |
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Urbana |
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| CCOP - Carle Cancer Center |
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| Clinical Trials Office - CCOP - Carle Cancer Center | |
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Indiana |
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Indianapolis |
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| Indiana University Melvin and Bren Simon Cancer Center |
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| Clinical Trials Office - Indiana University Cancer Center | |
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| St. Vincent Indianapolis Hospital |
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| Clinical Trials Office - St. Vincent Indianapolis Hospital | |
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Kentucky |
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Louisville |
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| Louisville Oncology at Norton Cancer Institute - Louisville |
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| Clinical Trials Office - Louisville Oncology | |
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Maryland |
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Baltimore |
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| Harry & Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center |
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| Clinical Trials Office - Harry & Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center | |
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|
Elkton MD |
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| Union Hospital Cancer Program at Union Hospital |
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| Mark Borowsky | |
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Michigan |
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Grand Rapids |
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| CCOP - Grand Rapids |
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| Marianne Lange, MD | |
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Kalamazoo |
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| West Michigan Cancer Center |
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| Clinical Trials Office - West Michigan Cancer Center | |
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Royal Oak |
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| William Beaumont Hospital - Royal Oak Campus |
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| Clinical Trials Office - William Beaumont Hospital - Royal Oak Campus | |
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Minnesota |
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Rochester |
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| Mayo Clinic Cancer Center |
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| Clinical Trials Office - All Mayo Clinic Locations | |
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Missouri |
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Kansas City |
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| CCOP - Kansas City |
|
| Rakesh Gaur, MD | |
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|
Springfield |
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| St. John's Regional Health Center |
|
| John Goodwin, MD | |
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Nevada |
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Las Vegas |
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| Women's Cancer Center - Lake Mead |
|
| Nick Spirtos, MD | |
|
New Mexico |
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Albuquerque |
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| University of New Mexico Cancer Center |
|
| Clinical Trials Office - University of New Mexico Cancer Center | |
|
New York |
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Manhasset |
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|
| Don Monti Comprehensive Cancer Center at North Shore University Hospital |
|
| Clinical Trials Office - Don Monti Comprehensive Cancer Center at North Shore University Hospital | |
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New York |
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| Mount Sinai Medical Center |
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| Linus Chuang | |
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North Carolina |
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Pinehurst |
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| FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center |
|
| Clinical Trials Office - FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center | |
|
Ohio |
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Cincinnati |
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| Charles M. Barrett Cancer Center at University Hospital |
|
| William Richards | |
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| Good Samaritan Hospital Cancer Treatment Center |
|
| Jack Basil, MD | |
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Cleveland |
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| Case Comprehensive Cancer Center |
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| Clinical Trials Office - Case Comprehensive Cancer Center | |
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Columbus |
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| Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center |
|
| Clinical Trials Office - OSU Comprehensive Cancer Center | |
| Email:
osu@emergingmed.com |
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| Mount Carmel Health - West Hospital |
|
| George Lewandowski, MD | |
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| Riverside Methodist Hospital Cancer Care |
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| Clinical Trials Office - Riverside Methodist Hospital Cancer Care | |
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|
Mentor |
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| Lake/University Ireland Cancer Center |
|
| Steven Waggoner, MD | |
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Oklahoma |
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Oklahoma City |
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| Oklahoma University Cancer Institute |
|
| Robert Mannel, MD | |
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Oregon |
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Portland |
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| Oregon Health and Science University Cancer Institute |
|
| Clinical Trials Office - Oregon Health and Science University Cancer Institute | |
| Email:
trials@ohsu.edu |
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Pennsylvania |
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Bryn Mawr |
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| Bryn Mawr Hospital |
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| Clinical Trials Office - Bryn Mawr Hospital | |
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|
Paoli |
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| Cancer Center of Paoli Memorial Hospital |
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| Clinical Trials Office - Cancer Center of Paoli Memorial Hospital | |
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|
Wynnewood |
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| Lankenau Cancer Center at Lankenau Hospital |
|
| Paul Gilman, MD | |
|
Rhode Island |
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Providence |
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| Women and Infants Hospital of Rhode Island |
|
| Clinical Trials Office - Women and Infants Hospital of Rhode Island | |
|
Tennessee |
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Nashville |
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|
| MBCCOP - Meharry Medical College - Nashville |
|
| Steven Wolff, MD | |
|
Texas |
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Amarillo |
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| Harrington Cancer Center |
|
| Clinical Trials Officec - Harrington Cancer Center | |
| Email:
ryokubaitis@harringtoncc.org |
|
Vermont |
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Burlington |
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|
| Fletcher Allen Health Care - University Health Center Campus |
|
| Clinical Trials Office - Fletcher Allen Health Care | |
|
Virginia |
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Charlottesville |
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|
| University of Virginia Cancer Center |
|
| Susan Modesitt | Ph: | 434-924-9333 | | 800-223-9173 |
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|
|
Richmond |
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| Virginia Commonwealth University Massey Cancer Center |
|
| Clinical Trials Office -Virginia Commonwealth University Massey Cancer Center | |
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|
Roanoke |
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| Carilion Gynecologic Oncology Associates |
|
| Dennis Scribner, MD | |
|
Wisconsin |
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Green Bay |
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| St. Vincent Hospital Regional Cancer Center |
|
| Clinical Trials Office - St. Vincent Hospital Regional Cancer Center | |
|