Phase
Condition
Osteoporosis
Cancer
Breast Cancer
Treatment
N/AClinical Study ID
Ages > 18 Female
Study Summary
Eligibility Criteria
Inclusion
Required Characteristics
Premenopausal women
≤ 6 months since last menstrual period
no prior bilateral oophorectomy
not on estrogen replacement therapy
if TAH is performed, with at least one intact ovary, or if > 3 months since last menstrual period, then patients must have premenopausal estrogen levels ≤ 1 month of study entry
Scheduled to undergo adjuvant or neoadjuvant chemotherapy for primary breast cancer (stages I-IIIB)
≥ 18 years of age
ECOG performance status (PS) 0 or 1
Contraindications
Hypercalcemia (calcium level > 1mg/dL above UNL ≤ 6 months
Hypocalcemia (calcium level > 0.5 mg/dL below UNL ≤ 6 months
Inability to stand or sit upright for at least 30 minutes
Known swallowing disorder
Bone mineral density T score of ≤ - 2.0 at the hip or lumbar spine
a patient with a T score of - 2.1 is ineligible
a patient with a T score of - 1.9 is eligible
- History of vertebral compression fracture
- Exception: traumatic fracture of the coccyx would not exclude a patient from participation
Corticosteroids at doses > 5 mg daily of prednison or equivalent for > 2 weeks in the past 6 months
Previous treatment with bisphosphonates
Diseases affecting bone metabolism (hyperthyroidism, hyperparathyroidism, and hypercortisolism)
History of severe renal impairment or creatinine > 2.0 mg/dL
Malabsorption syndrome
Estrogen replacement therapy
Oral contraceptive use
Prior bilateral oophorectomy
Pregnant women
Nursing women
Women of childbearing potential who are unwilling to employ adequate contraception (condoms, diaphragm, injections, intrauterine device [IUD], surgical sterilization, abstinence, etc.)
This study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown
- Dental extraction, root canal, or implants ≤ 3 months prior to registration or planned during study treatment
Study Design
Study Description
Connect with a study center
Allan Blair Cancer Centre at Pasqua Hospital
Regina, Saskatchewan S4T 7T1
CanadaSite Not Available
Mobile Infirmary Medical Center
Mobile, Alabama 36652-2144
United StatesSite Not Available
Mayo Clinic Scottsdale
Scottsdale, Arizona 85259
United StatesSite Not Available
Aurora Presbyterian Hospital
Aurora, Colorado 80012
United StatesSite Not Available
Boulder Community Hospital
Boulder, Colorado 80301-9019
United StatesSite Not Available
Penrose Cancer Center at Penrose Hospital
Colorado Springs, Colorado 80933
United StatesSite Not Available
CCOP - Colorado Cancer Research Program, Incorporated
Denver, Colorado 80224-2522
United StatesSite Not Available
Porter Adventist Hospital
Denver, Colorado 80210
United StatesSite Not Available
Presbyterian - St. Luke's Medical Center
Denver, Colorado 80218
United StatesSite Not Available
Rose Medical Center
Denver, Colorado 80220
United StatesSite Not Available
St. Joseph Hospital
Denver, Colorado 80218
United StatesSite Not Available
Swedish Medical Center
Englewood, Colorado 80110
United StatesSite Not Available
Sky Ridge Medical Center
Lone Tree, Colorado 80124
United StatesSite Not Available
Hope Cancer Care Center at Longmont United Hospital
Longmont, Colorado 80502
United StatesSite Not Available
St. Mary-Corwin Regional Medical Center
Pueblo, Colorado 81004
United StatesSite Not Available
North Suburban Medical Center
Thorton, Colorado 80229
United StatesSite Not Available
Gainesville, Florida 32605
United StatesSite Not Available
Mayo Clinic - Jacksonville
Jacksonville, Florida 32224
United StatesSite Not Available
CCOP - Atlanta Regional
Atlanta, Georgia 30342
United StatesSite Not Available
Northside Hospital Cancer Center
Atlanta, Georgia 30342-1611
United StatesSite Not Available
Piedmont Hospital
Atlanta, Georgia 30309
United StatesSite Not Available
Saint Joseph's Hospital of Atlanta
Atlanta, Georgia 30342-1701
United StatesSite Not Available
MBCCOP-Medical College of Georgia Cancer Center
Augusta, Georgia 30912
United StatesSite Not Available
WellStar Cobb Hospital
Austell, Georgia 30106
United StatesSite Not Available
Charles B. Eberhart Cancer Center at DeKalb Medical Center
Decatur, Georgia 30033
United StatesSite Not Available
Gwinnett Medical Center
Lawrenceville, Georgia 30045
United StatesSite Not Available
Kennestone Cancer Center at Wellstar Kennestone Hospital
Marietta, Georgia 30060
United StatesSite Not Available
Southern Regional Medical Center
Riverdale, Georgia 30274-2600
United StatesSite Not Available
Rush-Copley Cancer Care Center
Aurora, Illinois 60507
United StatesSite Not Available
St. Joseph Medical Center
Bloomington, Illinois 61701
United StatesSite Not Available
Graham Hospital
Canton, Illinois 61520
United StatesSite Not Available
Memorial Hospital
Carthage, Illinois 62321
United StatesSite Not Available
Eureka Community Hospital
Eureka, Illinois 61530
United StatesSite Not Available
Galesburg Clinic
Galesburg, Illinois 61401
United StatesSite Not Available
Galesburg Cottage Hospital
Galesburg, Illinois 61401
United StatesSite Not Available
InterCommunity Cancer Center of Western Illinois
Galesburg, Illinois 61401
United StatesSite Not Available
Mason District Hospital
Havana, Illinois 62644
United StatesSite Not Available
Hopedale Medical Complex
Hopedale, Illinois 61747
United StatesSite Not Available
Joliet Oncology Hematology Associates, Limited - West
Joliet, Illinois 60435
United StatesSite Not Available
Kewanee Hospital
Kewanee, Illinois 61443
United StatesSite Not Available
McDonough District Hospital
Macomb, Illinois 61455
United StatesSite Not Available
Trinity Medical Center - East
Moline, Illinois 61265
United StatesSite Not Available
Moline, Illinois 61265
United StatesSite Not Available
BroMenn Regional Medical Center
Normal, Illinois 61761
United StatesSite Not Available
Community Cancer Center
Normal, Illinois 61761
United StatesSite Not Available
Community Hospital of Ottawa
Ottawa, Illinois 61350
United StatesSite Not Available
Oncology Hematology Associates of Central Illinois - Ottawa
Ottawa, Illinois 61350
United StatesSite Not Available
Cancer Treatment Center at Pekin Hospital
Pekin, Illinois 61554
United StatesSite Not Available
CCOP - Illinois Oncology Research Association
Peoria, Illinois 61615
United StatesSite Not Available
Methodist Medical Center of Illinois
Peoria, Illinois 61636
United StatesSite Not Available
OSF St. Francis Medical Center
Peoria, Illinois 61637
United StatesSite Not Available
Oncology/Hematology Associates of Central Illinois, P.C.
Peoria, Illinois 61615
United StatesSite Not Available
Proctor Hospital
Peoria, Illinois 61614
United StatesSite Not Available
Illinois Valley Community Hospital
Peru, Illinois 61354
United StatesSite Not Available
Perry Memorial Hospital
Princeton, Illinois 61356
United StatesSite Not Available
St. Margaret's Hospital
Spring Valley, Illinois 61362
United StatesSite Not Available
Valley Cancer Center
Spring Valley, Illinois 61362
United StatesSite Not Available
CCOP - Carle Cancer Center
Urbana, Illinois 61801
United StatesSite Not Available
Carle Cancer Center at Carle Foundation Hospital
Urbana, Illinois 61801
United StatesSite Not Available
Saint Anthony Memorial Health Centers
Michigan City, Indiana 46360
United StatesSite Not Available
McFarland Clinic, P. C.
Ames, Iowa 50010
United StatesSite Not Available
Bettendorf, Iowa 52722
United StatesSite Not Available
Saint Anthony Regional Hospital
Carroll, Iowa 51401
United StatesSite Not Available
Cedar Rapids Oncology Associates
Cedar Rapids, Iowa 52403
United StatesSite Not Available
Mercy Regional Cancer Center at Mercy Medical Center
Cedar Rapids, Iowa 52403
United StatesSite Not Available
St. Luke's Hospital
Cedar Rapids, Iowa 52402
United StatesSite Not Available
Alegent Health Mercy Hospital
Council Bluffs, Iowa 51503
United StatesSite Not Available
CCOP - Iowa Oncology Research Association
Des Moines, Iowa 50309
United StatesSite Not Available
John Stoddard Cancer Center at Iowa Lutheran Hospital
Des Moines, Iowa 50316-2301
United StatesSite Not Available
John Stoddard Cancer Center at Iowa Methodist Medical Center
Des Moines, Iowa 50309
United StatesSite Not Available
Medical Oncology and Hematology Associates at John Stoddard Cancer Center
Des Moines, Iowa 50309
United StatesSite Not Available
Medical Oncology and Hematology Associates at Mercy Cancer Center
Des Moines, Iowa 50314
United StatesSite Not Available
Mercy Cancer Center at Mercy Medical Center - Des Moines
Des Moines, Iowa 50314
United StatesSite Not Available
Mercy Capitol Hospital
Des Moines, Iowa 50307
United StatesSite Not Available
Alegent Health Community Memorial Hospital
Missouri Valley, Iowa 51555-1199
United StatesSite Not Available
Burgess Health Center
Onawa, Iowa 51040
United StatesSite Not Available
Ottumwa Regional Health Center Cancer Center
Ottumwa, Iowa 52501
United StatesSite Not Available
Mercy Medical Center - Sioux City
Sioux City, Iowa 51104
United StatesSite Not Available
Siouxland Hematology-Oncology Associates at June E. Nylen Cancer Center
Sioux City, Iowa 51101
United StatesSite Not Available
Siouxland Regional Cancer Center
Sioux City, Iowa 51101
United StatesSite Not Available
St. Luke's Regional Medical Center
Sioux City, Iowa 51104
United StatesSite Not Available
Medical Oncology and Hematology Associates - West Des Moines
West Des Moines, Iowa 50266
United StatesSite Not Available
Cancer Center of Kansas, P.A. - Chanute
Chanute, Kansas 66720
United StatesSite Not Available
Cancer Center of Kansas, P.A. - Dodge City
Dodge City, Kansas 67801
United StatesSite Not Available
Cancer Center of Kansas, P.A. - El Dorado
El Dorado, Kansas 67042
United StatesSite Not Available
Cancer Center of Kansas, P.A. - Kingman
Kingman, Kansas 67068
United StatesSite Not Available
Southwest Medical Center
Liberal, Kansas 67901
United StatesSite Not Available
Cancer Center of Kansas, P.A. - Newton
Newton, Kansas 67114
United StatesSite Not Available
Cancer Center of Kansas, P.A. - Parsons
Parsons, Kansas 67357
United StatesSite Not Available
Cancer Center of Kansas, P.A. - Pratt
Pratt, Kansas 67124
United StatesSite Not Available
Cancer Center of Kansas, P.A. - Salina
Salina, Kansas 67042
United StatesSite Not Available
Cancer Center of Kansas, P.A. - Wellington
Wellington, Kansas 67152
United StatesSite Not Available
Associates in Womens Health, P.A. - North Review
Wichita, Kansas 67203
United StatesSite Not Available
CCOP - Wichita
Wichita, Kansas 67214
United StatesSite Not Available
Cancer Center of Kansas, P.A. - Medical Arts Tower
Wichita, Kansas 67208
United StatesSite Not Available
Cancer Center of Kansas, P.A. - Wichita
Wichita, Kansas 67214
United StatesSite Not Available
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita, Kansas 67214
United StatesSite Not Available
Cancer Center of Kansas, P.A. - Winfield
Winfield, Kansas 67156
United StatesSite Not Available
Ochsner Clinic of Baton Rouge
Baton Rouge, Louisiana 708169990
United StatesSite Not Available
Terrebonne General Medical Center
Houma, Louisiana 70360
United StatesSite Not Available
CCOP - Ochsner
New Orleans, Louisiana 70121
United StatesSite Not Available
Ochsner Cancer Institute at Ochsner Clinic Foundation
New Orleans, Louisiana 70121
United StatesSite Not Available
Hickman Cancer Center at Bixby Medical Center
Adrian, Michigan 49221
United StatesSite Not Available
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan 48106
United StatesSite Not Available
St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital
Ann Arbor, Michigan 48106-0995
United StatesSite Not Available
Green Bay Oncology, Limited - Escanaba
Escanaba, Michigan 49431
United StatesSite Not Available
Green Bay Oncology, Limited - Iron Mountain
Iron Mountain, Michigan 49801
United StatesSite Not Available
Haematology-Oncology Associates of Ohio and Michigan, P.C.
Lambertville, Michigan 48144
United StatesSite Not Available
Community Cancer Center of Monroe
Monroe, Michigan 48162
United StatesSite Not Available
Mercy Memorial Hospital System
Monroe, Michigan 48162
United StatesSite Not Available
MeritCare Clinic - Bemidji
Bemidji, Minnesota 56601
United StatesSite Not Available
Fairview Ridges Hospital
Burnsville, Minnesota 55337
United StatesSite Not Available
Mercy and Unity Cancer Center at Mercy Hospital
Coon Rapids, Minnesota 55433
United StatesSite Not Available
CCOP - Duluth
Duluth, Minnesota 55805
United StatesSite Not Available
Miller-Dwan Medical Center
Duluth, Minnesota 55805
United StatesSite Not Available
St. Mary's - Duluth Clinic Cancer Center
Duluth, Minnesota 55805
United StatesSite Not Available
Fairview Southdale Hospital
Edina, Minnesota 55435
United StatesSite Not Available
Mercy and Unity Cancer Center at Unity Hospital
Fridley, Minnesota 55432
United StatesSite Not Available
Immanuel St. Joseph's Clinic
Mankato, Minnesota 56002
United StatesSite Not Available
Virginia Piper Cancer Institute at Abbott-Northwestern Hospital
Minneapolis, Minnesota 55407
United StatesSite Not Available
Hubert H. Humphrey Cancer Center at North Memorial Medical Center
Robbinsdale, Minnesota 55422-2900
United StatesSite Not Available
Mayo Clinic Cancer Center
Rochester, Minnesota 55905
United StatesSite Not Available
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota 55416
United StatesSite Not Available
Park Nicollet Health Services
St. Louis Park, Minnesota 55416
United StatesSite Not Available
United Hospital
St. Paul, Minnesota 55102
United StatesSite Not Available
Ridgeview Medical Center
Waconia, Minnesota 55387
United StatesSite Not Available
Hattiesburg Clinic, P.A.
Hattiesburg, Mississippi 39401
United StatesSite Not Available
CCOP - Montana Cancer Consortium
Billings, Montana 59101
United StatesSite Not Available
Deaconess Billings Clinic - Downtown
Billings, Montana 59107-7000
United StatesSite Not Available
Deaconess Billings Clinic Cancer Center
Billings, Montana 59107-5100
United StatesSite Not Available
Hematology-Oncology Centers of the Northern Rockies - Billings
Billings, Montana 59101
United StatesSite Not Available
Northern Rockies Radiation Oncology Center
Billings, Montana 59101
United StatesSite Not Available
St. Vincent Healthcare
Billings, Montana 59101
United StatesSite Not Available
Bozeman Deaconess Hospital
Bozeman, Montana 59715
United StatesSite Not Available
Internal Medicine Associates of Bozeman
Bozeman, Montana 59715
United StatesSite Not Available
St. James Community Hospital
Butte, Montana 59701
United StatesSite Not Available
Great Falls Clinic
Great Falls, Montana 59405
United StatesSite Not Available
St. Peter's Hospital
Helena, Montana 59601
United StatesSite Not Available
Glacier Oncology, PLLC
Kalispell, Montana 59901
United StatesSite Not Available
Kalispell Medical Oncology
Kalispell, Montana 59901
United StatesSite Not Available
Eastern Montana Cancer Center
Miles City, Montana 59301
United StatesSite Not Available
Community Medical Center
Missoula, Montana 59801
United StatesSite Not Available
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
Missoula, Montana 59807
United StatesSite Not Available
Montana Cancer Specialists at Montana Cancer Center
Missoula, Montana 59807-7877
United StatesSite Not Available
Bryan LGH Medical Center West
Lincoln, Nebraska 68502
United StatesSite Not Available
Cancer Resource Center - Lincoln
Lincoln, Nebraska 68510
United StatesSite Not Available
St. Elizabeth Regional Medical Center
Lincoln, Nebraska 68510
United StatesSite Not Available
Bergan Mercy Medical Center
Omaha, Nebraska 68124
United StatesSite Not Available
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska 68106
United StatesSite Not Available
Creighton University Medical Center
Omaha, Nebraska 68131-2197
United StatesSite Not Available
Immanuel Medical Center
Omaha, Nebraska 68122
United StatesSite Not Available
Midlands Cancer Center at Midlands Community Hospital
Papillion, Nebraska 68046-4194
United StatesSite Not Available
Rutherford Hospital
Rutherfordton, North Carolina 28139
United StatesSite Not Available
Bismarck Cancer Center
Bismarck, North Dakota 58501
United StatesSite Not Available
Cancer Care Center at Medcenter One Hospital
Bismarck, North Dakota 58501
United StatesSite Not Available
Mid Dakota Clinic, P. C.
Bismarck, North Dakota 58501
United StatesSite Not Available
St. Alexius Medical Center
Bismarck, North Dakota 58502
United StatesSite Not Available
CCOP - MeritCare Hospital
Fargo, North Dakota 58122
United StatesSite Not Available
MeritCare Medical Group
Fargo, North Dakota 58122
United StatesSite Not Available
Altru Cancer Center at Altru Hospital
Grand Forks, North Dakota 58201
United StatesSite Not Available
Wood County Oncology Center
Bowling Green, Ohio 43402
United StatesSite Not Available
Blanchard Valley Medical Associates
Findlay, Ohio 45840
United StatesSite Not Available
Fremont Memorial Hospital
Fremont, Ohio 43420
United StatesSite Not Available
Kenton Oncology, Incorporated
Kenton, Ohio 43326
United StatesSite Not Available
Lima Memorial Hospital
Lima, Ohio 45804
United StatesSite Not Available
Northwest Ohio Oncology Center
Maumee, Ohio 43537
United StatesSite Not Available
St. Luke's Hospital
Maumee, Ohio 43537
United StatesSite Not Available
St. Charles Mercy Hospital
Oregon, Ohio 43616
United StatesSite Not Available
Toledo Clinic - Oregon
Oregon, Ohio 43616
United StatesSite Not Available
Firelands Regional Medical Center
Sandusky, Ohio 44870
United StatesSite Not Available
North Coast Cancer Care, Incorporated
Sandusky, Ohio 44870
United StatesSite Not Available
Promedica Cancer Center at Flower Hospital
Sylvania, Ohio 43560
United StatesSite Not Available
Mercy Hospital of Tiffin
Tiffin, Ohio 44883
United StatesSite Not Available
CCOP - Toledo Community Hospital
Toledo, Ohio 43623
United StatesSite Not Available
Medical College of Ohio Cancer Institute
Toledo, Ohio 43614
United StatesSite Not Available
St. Vincent Mercy Medical Center
Toledo, Ohio 43608
United StatesSite Not Available
Toledo Clinic, Incorporated - Main Clinic
Toledo, Ohio 43623
United StatesSite Not Available
Toledo Hospital
Toledo, Ohio 43606
United StatesSite Not Available
Toledo Surgical Specialists
Toledo, Ohio 43623
United StatesSite Not Available
Fulton County Health Center
Wauseon, Ohio 43567
United StatesSite Not Available
Natalie Warren Bryant Cancer Center at St. Francis Hospital
Tulsa, Oklahoma 74136
United StatesSite Not Available
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
Allentown, Pennsylvania 18105
United StatesSite Not Available
Geisinger Medical Center
Danville, Pennsylvania 17822-0001
United StatesSite Not Available
Geisinger Medical Group
State College, Pennsylvania 16801
United StatesSite Not Available
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
Wilkes-Barre, Pennsylvania 18711
United StatesSite Not Available
Rose Ramer Cancer Clinic at Anderson Area Medical Center
Anderson, South Carolina 29621
United StatesSite Not Available
CCOP - Upstate Carolina
Spartanburg, South Carolina 29303
United StatesSite Not Available
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Spartanburg, South Carolina 29303
United StatesSite Not Available
Rapid City Regional Hospital
Rapid City, South Dakota 57701
United StatesSite Not Available
Avera McKennan Hospital and University Health Center
Sioux Falls, South Dakota 57105-1080
United StatesSite Not Available
Medical X-Ray Center, P. C.
Sioux Falls, South Dakota 57105
United StatesSite Not Available
Sioux Valley Hospital and University of South Dakota Medical Center
Sioux Falls, South Dakota 57117-5039
United StatesSite Not Available
Green Bay Oncology, Limited at St. Mary's Hospital
Green Bay, Wisconsin 54303
United StatesSite Not Available
Green Bay Oncology, Limited at St. Vincent Hospital
Green Bay, Wisconsin 54301-3526
United StatesSite Not Available
St. Mary's Hospital Medical Center - Green Bay
Green Bay, Wisconsin 54303
United StatesSite Not Available
St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin 54307-3508
United StatesSite Not Available
Green Bay Oncology, Limited - Oconto Falls
Oconto Falls, Wisconsin 54154
United StatesSite Not Available
Green Bay Oncology, Limited - Sturgeon Bay
Sturgeon Bay, Wisconsin 54235
United StatesSite Not Available
Welch Cancer Center at Sheridan Memorial Hospital
Sheridan, Wyoming 82801
United StatesSite Not Available
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