Risedronate in Preventing Bone Loss in Premenopausal Women Receiving Chemotherapy for Primary Breast Cancer
NCT ID: NCT00054418
Last Updated: 2016-07-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
216 participants
INTERVENTIONAL
2003-03-31
2008-05-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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calcium carbonate, vitamin D and risedronate
Patients receive calcium carbonate 600 mg daily, vitamin D 400 U daily and risedronate 35 mg weekly.
calcium carbonate
calcium 600 mg daily administered orally for one year
vitamin D
vitamin D 400 U daily administered orally for one year
risedronate sodium
risedronate 35 mg weekly administered orally
calcium carbonate, vitamin D and placebo
Patients receive calcium carbonate 600 mg daily, vitamin D 400 U daily and placebo weekly.
calcium carbonate
calcium 600 mg daily administered orally for one year
vitamin D
vitamin D 400 U daily administered orally for one year
placebo
placebo tablet weekly administered orally for one year
Interventions
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calcium carbonate
calcium 600 mg daily administered orally for one year
vitamin D
vitamin D 400 U daily administered orally for one year
risedronate sodium
risedronate 35 mg weekly administered orally
placebo
placebo tablet weekly administered orally for one year
Eligibility Criteria
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Inclusion Criteria
6. History of vertebral compression fracture
* Exception: traumatic fracture of the coccyx would not exclude a patient from participation
7. Corticosteroids at doses \> 5 mg daily of prednison or equivalent for \> 2 weeks in the past 6 months
8. Previous treatment with bisphosphonates
9. Diseases affecting bone metabolism (hyperthyroidism, hyperparathyroidism, and hypercortisolism)
10. History of severe renal impairment or creatinine \> 2.0 mg/dL
11. Malabsorption syndrome
12. Estrogen replacement therapy
13. Oral contraceptive use
14. Prior bilateral oophorectomy
15. 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
16. Dental extraction, root canal, or implants ≤ 3 months prior to registration or planned during study treatment
18 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Alliance for Clinical Trials in Oncology
OTHER
Responsible Party
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Principal Investigators
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Stephanie Hines, MD
Role: STUDY_CHAIR
Mayo Clinic
Locations
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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
Saint Louis Park, Minnesota, United States
United Hospital
Saint 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
Countries
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References
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Hines SL, Mincey BA, Sloan JA, Thomas SP, Chottiner E, Loprinzi CL, Carlson MD, Atherton PJ, Salim M, Perez EA. Phase III randomized, placebo-controlled, double-blind trial of risedronate for the prevention of bone loss in premenopausal women undergoing chemotherapy for primary breast cancer. J Clin Oncol. 2009 Mar 1;27(7):1047-53. doi: 10.1200/JCO.2008.19.1783. Epub 2008 Dec 15.
Adams A, Jakob T, Huth A, Monsef I, Ernst M, Kopp M, Caro-Valenzuela J, Wockel A, Skoetz N. Bone-modifying agents for reducing bone loss in women with early and locally advanced breast cancer: a network meta-analysis. Cochrane Database Syst Rev. 2024 Jul 9;7(7):CD013451. doi: 10.1002/14651858.CD013451.pub2.
Other Identifiers
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NCI-2012-02515
Identifier Type: REGISTRY
Identifier Source: secondary_id
CDR0000270449
Identifier Type: REGISTRY
Identifier Source: secondary_id
NCCTG-N02C1
Identifier Type: -
Identifier Source: org_study_id
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