Spots Global Cancer Trial Database for Risedronate in Preventing Bone Loss in Premenopausal Women Receiving Chemotherapy for Primary Breast Cancer
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Trial Identification
Brief Title: Risedronate in Preventing Bone Loss in Premenopausal Women Receiving Chemotherapy for Primary Breast Cancer
Official Title: A Phase III Randomized, Placebo-Controlled, Double-Blind Trial Of Risedronate (Actonel) For Prevention Of Bone Loss In Premenopausal Women Undergoing Chemotherapy For Primary Breast Carcinoma
Study ID: NCT00054418
Study Description
Brief Summary: RATIONALE: Preventing bone loss in patients who are receiving chemotherapy for breast cancer may decrease the risk of fractures and may help patients live more comfortably. It is not yet known whether calcium is more effective with or without risedronate in preventing bone loss. PURPOSE: This randomized phase III trial is studying two forms of calcium with or without risedronate to compare how well they work in preventing bone loss in premenopausal women who are receiving chemotherapy for primary stage I, stage II, stage IIIA, or stage IIIB breast cancer.
Detailed Description: OUTLINE: This is a randomized, placebo-controlled, double-blind study. Patients are stratified according to planned tamoxifen therapy (yes vs no vs undecided), planned taxane therapy (yes vs no vs undecided), time from last menses (1-3 months vs longer than 3 months to 6 months), and age (under 40 vs 40 to 49 vs 50 and over). Patients are randomized to 1 of 2 treatment arms. In both arms, treatment begins during the first month of chemotherapy and continues for 1 year in the absence of unacceptable toxicity. For more information regarding the treatment arms, please see the "Arms" section below. Questionnaires about cessation of menses, ovarian failure, and menopausal symptoms are completed at baseline, monthly during chemotherapy, at 6 months, and then at 1 and 2 years. Patients are followed for 1 year. A summary of study goals is listed below. Goals: 1. To evaluate the effectiveness of risedronate at a weekly oral dose of 35 mg versus placebo in the prevention of bone loss in premenopausal women undergoing adjuvant or neoadjuvant chemotherapy for primary breast cancer. 2. To evaluate the degree of bone loss over one year in premenopausal women undergoing adjuvant chemotherapy for primary breast cancer according to menopausal status at one year after therapy begins. 3. To evaluate the relationship of current climacteric symptoms, menstrual and reproductive history, and chemotherapy regimen with ovarian failure (permanent cessation of menses) in premenopausal women undergoing adjuvant or neoadjuvant chemotherapy for primary breast cancer. 4. To evaluate the relationship of baseline serum estradiol levels with ovarian failure in premenopausal women undergoing adjuvant or neoadjuvant chemotherapy for primary breast cancer.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Mobile Infirmary Medical Center, Mobile, Alabama, United States
Mayo Clinic Scottsdale, Scottsdale, Arizona, United States
Aurora Presbyterian Hospital, Aurora, Colorado, United States
Boulder Community Hospital, Boulder, Colorado, United States
Penrose Cancer Center at Penrose Hospital, Colorado Springs, Colorado, United States
Porter Adventist Hospital, Denver, Colorado, United States
Presbyterian - St. Luke's Medical Center, Denver, Colorado, United States
St. Joseph Hospital, Denver, Colorado, United States
Rose Medical Center, Denver, Colorado, United States
CCOP - Colorado Cancer Research Program, Incorporated, Denver, Colorado, United States
Swedish Medical Center, Englewood, Colorado, United States
Sky Ridge Medical Center, Lone Tree, Colorado, United States
Hope Cancer Care Center at Longmont United Hospital, Longmont, Colorado, United States
St. Mary-Corwin Regional Medical Center, Pueblo, Colorado, United States
North Suburban Medical Center, Thorton, Colorado, United States
, Gainesville, Florida, United States
Mayo Clinic - Jacksonville, Jacksonville, Florida, United States
Piedmont Hospital, Atlanta, Georgia, United States
Northside Hospital Cancer Center, Atlanta, Georgia, United States
Saint Joseph's Hospital of Atlanta, Atlanta, Georgia, United States
CCOP - Atlanta Regional, Atlanta, Georgia, United States
MBCCOP-Medical College of Georgia Cancer Center, Augusta, Georgia, United States
WellStar Cobb Hospital, Austell, Georgia, United States
Charles B. Eberhart Cancer Center at DeKalb Medical Center, Decatur, Georgia, United States
Gwinnett Medical Center, Lawrenceville, Georgia, United States
Kennestone Cancer Center at Wellstar Kennestone Hospital, Marietta, Georgia, United States
Southern Regional Medical Center, Riverdale, Georgia, United States
Rush-Copley Cancer Care Center, Aurora, Illinois, United States
St. Joseph Medical Center, Bloomington, Illinois, United States
Graham Hospital, Canton, Illinois, United States
Memorial Hospital, Carthage, Illinois, United States
Eureka Community Hospital, Eureka, Illinois, United States
Galesburg Clinic, Galesburg, Illinois, United States
Galesburg Cottage Hospital, Galesburg, Illinois, United States
InterCommunity Cancer Center of Western Illinois, Galesburg, Illinois, United States
Mason District Hospital, Havana, Illinois, United States
Hopedale Medical Complex, Hopedale, Illinois, United States
Joliet Oncology Hematology Associates, Limited - West, Joliet, Illinois, United States
Kewanee Hospital, Kewanee, Illinois, United States
McDonough District Hospital, Macomb, Illinois, United States
Trinity Medical Center - East, Moline, Illinois, United States
, Moline, Illinois, United States
BroMenn Regional Medical Center, Normal, Illinois, United States
Community Cancer Center, Normal, Illinois, United States
Community Hospital of Ottawa, Ottawa, Illinois, United States
Oncology Hematology Associates of Central Illinois - Ottawa, Ottawa, Illinois, United States
Cancer Treatment Center at Pekin Hospital, Pekin, Illinois, United States
Proctor Hospital, Peoria, Illinois, United States
CCOP - Illinois Oncology Research Association, Peoria, Illinois, United States
Oncology/Hematology Associates of Central Illinois, P.C., Peoria, Illinois, United States
Methodist Medical Center of Illinois, Peoria, Illinois, United States
OSF St. Francis Medical Center, Peoria, Illinois, United States
Illinois Valley Community Hospital, Peru, Illinois, United States
Perry Memorial Hospital, Princeton, Illinois, United States
St. Margaret's Hospital, Spring Valley, Illinois, United States
Valley Cancer Center, Spring Valley, Illinois, United States
Carle Cancer Center at Carle Foundation Hospital, Urbana, Illinois, United States
CCOP - Carle Cancer Center, Urbana, Illinois, United States
Saint Anthony Memorial Health Centers, Michigan City, Indiana, United States
McFarland Clinic, P. C., Ames, Iowa, United States
, Bettendorf, Iowa, United States
Saint Anthony Regional Hospital, Carroll, Iowa, United States
St. Luke's Hospital, Cedar Rapids, Iowa, United States
Cedar Rapids Oncology Associates, Cedar Rapids, Iowa, United States
Mercy Regional Cancer Center at Mercy Medical Center, Cedar Rapids, Iowa, United States
Alegent Health Mercy Hospital, Council Bluffs, Iowa, United States
Mercy Capitol Hospital, Des Moines, Iowa, United States
CCOP - Iowa Oncology Research Association, Des Moines, Iowa, United States
John Stoddard Cancer Center at Iowa Methodist Medical Center, Des Moines, Iowa, United States
Medical Oncology and Hematology Associates at John Stoddard Cancer Center, Des Moines, Iowa, United States
Medical Oncology and Hematology Associates at Mercy Cancer Center, Des Moines, Iowa, United States
Mercy Cancer Center at Mercy Medical Center - Des Moines, Des Moines, Iowa, United States
John Stoddard Cancer Center at Iowa Lutheran Hospital, Des Moines, Iowa, United States
Alegent Health Community Memorial Hospital, Missouri Valley, Iowa, United States
Burgess Health Center, Onawa, Iowa, United States
Ottumwa Regional Health Center Cancer Center, Ottumwa, Iowa, United States
Siouxland Hematology-Oncology Associates at June E. Nylen Cancer Center, Sioux City, Iowa, United States
Siouxland Regional Cancer Center, Sioux City, Iowa, United States
Mercy Medical Center - Sioux City, Sioux City, Iowa, United States
St. Luke's Regional Medical Center, Sioux City, Iowa, United States
Medical Oncology and Hematology Associates - West Des Moines, West Des Moines, Iowa, United States
Cancer Center of Kansas, P.A. - Chanute, Chanute, Kansas, United States
Cancer Center of Kansas, P.A. - Dodge City, Dodge City, Kansas, United States
Cancer Center of Kansas, P.A. - El Dorado, El Dorado, Kansas, United States
Cancer Center of Kansas, P.A. - Kingman, Kingman, Kansas, United States
Southwest Medical Center, Liberal, Kansas, United States
Cancer Center of Kansas, P.A. - Newton, Newton, Kansas, United States
Cancer Center of Kansas, P.A. - Parsons, Parsons, Kansas, United States
Cancer Center of Kansas, P.A. - Pratt, Pratt, Kansas, United States
Cancer Center of Kansas, P.A. - Salina, Salina, Kansas, United States
Cancer Center of Kansas, P.A. - Wellington, Wellington, Kansas, United States
Associates in Womens Health, P.A. - North Review, Wichita, Kansas, United States
Cancer Center of Kansas, P.A. - Medical Arts Tower, Wichita, Kansas, United States
Cancer Center of Kansas, P.A. - Wichita, Wichita, Kansas, United States
CCOP - Wichita, Wichita, Kansas, United States
Via Christi Cancer Center at Via Christi Regional Medical Center, Wichita, Kansas, United States
Cancer Center of Kansas, P.A. - Winfield, Winfield, Kansas, United States
Ochsner Clinic of Baton Rouge, Baton Rouge, Louisiana, United States
Terrebonne General Medical Center, Houma, Louisiana, United States
CCOP - Ochsner, New Orleans, Louisiana, United States
Ochsner Cancer Institute at Ochsner Clinic Foundation, New Orleans, Louisiana, United States
Hickman Cancer Center at Bixby Medical Center, Adrian, Michigan, United States
St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital, Ann Arbor, Michigan, United States
CCOP - Michigan Cancer Research Consortium, Ann Arbor, Michigan, United States
Green Bay Oncology, Limited - Escanaba, Escanaba, Michigan, United States
Green Bay Oncology, Limited - Iron Mountain, Iron Mountain, Michigan, United States
Haematology-Oncology Associates of Ohio and Michigan, P.C., Lambertville, Michigan, United States
Community Cancer Center of Monroe, Monroe, Michigan, United States
Mercy Memorial Hospital System, Monroe, Michigan, United States
MeritCare Clinic - Bemidji, Bemidji, Minnesota, United States
Fairview Ridges Hospital, Burnsville, Minnesota, United States
Mercy and Unity Cancer Center at Mercy Hospital, Coon Rapids, Minnesota, United States
CCOP - Duluth, Duluth, Minnesota, United States
Miller-Dwan Medical Center, Duluth, Minnesota, United States
St. Mary's - Duluth Clinic Cancer Center, Duluth, Minnesota, United States
Fairview Southdale Hospital, Edina, Minnesota, United States
Mercy and Unity Cancer Center at Unity Hospital, Fridley, Minnesota, United States
Immanuel St. Joseph's Clinic, Mankato, Minnesota, United States
Virginia Piper Cancer Institute at Abbott-Northwestern Hospital, Minneapolis, Minnesota, United States
Hubert H. Humphrey Cancer Center at North Memorial Medical Center, Robbinsdale, Minnesota, United States
Mayo Clinic Cancer Center, Rochester, Minnesota, United States
CCOP - Metro-Minnesota, Saint Louis Park, Minnesota, United States
Park Nicollet Health Services, St. Louis Park, Minnesota, United States
United Hospital, St. Paul, Minnesota, United States
Ridgeview Medical Center, Waconia, Minnesota, United States
Hattiesburg Clinic, P.A., Hattiesburg, Mississippi, United States
CCOP - Montana Cancer Consortium, Billings, Montana, United States
Hematology-Oncology Centers of the Northern Rockies - Billings, Billings, Montana, United States
Northern Rockies Radiation Oncology Center, Billings, Montana, United States
St. Vincent Healthcare, Billings, Montana, United States
Deaconess Billings Clinic Cancer Center, Billings, Montana, United States
Deaconess Billings Clinic - Downtown, Billings, Montana, United States
Bozeman Deaconess Hospital, Bozeman, Montana, United States
Internal Medicine Associates of Bozeman, Bozeman, Montana, United States
St. James Community Hospital, Butte, Montana, United States
Great Falls Clinic, Great Falls, Montana, United States
St. Peter's Hospital, Helena, Montana, United States
Glacier Oncology, PLLC, Kalispell, Montana, United States
Kalispell Medical Oncology, Kalispell, Montana, United States
Eastern Montana Cancer Center, Miles City, Montana, United States
Community Medical Center, Missoula, Montana, United States
Montana Cancer Specialists at Montana Cancer Center, Missoula, Montana, United States
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center, Missoula, Montana, United States
Bryan LGH Medical Center West, Lincoln, Nebraska, United States
Cancer Resource Center - Lincoln, Lincoln, Nebraska, United States
St. Elizabeth Regional Medical Center, Lincoln, Nebraska, United States
CCOP - Missouri Valley Cancer Consortium, Omaha, Nebraska, United States
Immanuel Medical Center, Omaha, Nebraska, United States
Bergan Mercy Medical Center, Omaha, Nebraska, United States
Creighton University Medical Center, Omaha, Nebraska, United States
Midlands Cancer Center at Midlands Community Hospital, Papillion, Nebraska, United States
Rutherford Hospital, Rutherfordton, North Carolina, United States
Bismarck Cancer Center, Bismarck, North Dakota, United States
Cancer Care Center at Medcenter One Hospital, Bismarck, North Dakota, United States
Mid Dakota Clinic, P. C., Bismarck, North Dakota, United States
St. Alexius Medical Center, Bismarck, North Dakota, United States
CCOP - MeritCare Hospital, Fargo, North Dakota, United States
MeritCare Medical Group, Fargo, North Dakota, United States
Altru Cancer Center at Altru Hospital, Grand Forks, North Dakota, United States
Wood County Oncology Center, Bowling Green, Ohio, United States
Blanchard Valley Medical Associates, Findlay, Ohio, United States
Fremont Memorial Hospital, Fremont, Ohio, United States
Kenton Oncology, Incorporated, Kenton, Ohio, United States
Lima Memorial Hospital, Lima, Ohio, United States
Northwest Ohio Oncology Center, Maumee, Ohio, United States
St. Luke's Hospital, Maumee, Ohio, United States
St. Charles Mercy Hospital, Oregon, Ohio, United States
Toledo Clinic - Oregon, Oregon, Ohio, United States
Firelands Regional Medical Center, Sandusky, Ohio, United States
North Coast Cancer Care, Incorporated, Sandusky, Ohio, United States
Promedica Cancer Center at Flower Hospital, Sylvania, Ohio, United States
Mercy Hospital of Tiffin, Tiffin, Ohio, United States
Toledo Hospital, Toledo, Ohio, United States
St. Vincent Mercy Medical Center, Toledo, Ohio, United States
Medical College of Ohio Cancer Institute, Toledo, Ohio, United States
CCOP - Toledo Community Hospital, Toledo, Ohio, United States
Toledo Clinic, Incorporated - Main Clinic, Toledo, Ohio, United States
Toledo Surgical Specialists, Toledo, Ohio, United States
Fulton County Health Center, Wauseon, Ohio, United States
Natalie Warren Bryant Cancer Center at St. Francis Hospital, Tulsa, Oklahoma, United States
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest, Allentown, Pennsylvania, United States
Geisinger Medical Center, Danville, Pennsylvania, United States
Geisinger Medical Group, State College, Pennsylvania, United States
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center, Wilkes-Barre, Pennsylvania, United States
Rose Ramer Cancer Clinic at Anderson Area Medical Center, Anderson, South Carolina, United States
CCOP - Upstate Carolina, Spartanburg, South Carolina, United States
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center, Spartanburg, South Carolina, United States
Rapid City Regional Hospital, Rapid City, South Dakota, United States
Avera McKennan Hospital and University Health Center, Sioux Falls, South Dakota, United States
Medical X-Ray Center, P. C., Sioux Falls, South Dakota, United States
Sioux Valley Hospital and University of South Dakota Medical Center, Sioux Falls, South Dakota, United States
Green Bay Oncology, Limited at St. Vincent Hospital, Green Bay, Wisconsin, United States
Green Bay Oncology, Limited at St. Mary's Hospital, Green Bay, Wisconsin, United States
St. Mary's Hospital Medical Center - Green Bay, Green Bay, Wisconsin, United States
St. Vincent Hospital Regional Cancer Center, Green Bay, Wisconsin, United States
Green Bay Oncology, Limited - Oconto Falls, Oconto Falls, Wisconsin, United States
Green Bay Oncology, Limited - Sturgeon Bay, Sturgeon Bay, Wisconsin, United States
Welch Cancer Center at Sheridan Memorial Hospital, Sheridan, Wyoming, United States
Allan Blair Cancer Centre at Pasqua Hospital, Regina, Saskatchewan, Canada
Contact Details
Name: Stephanie Hines, MD
Affiliation: Mayo Clinic
Role: STUDY_CHAIR
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