Risedronate in Preventing Bone Loss in Premenopausal Women Receiving Chemotherapy for Primary Breast Cancer
Breast Cancer, Osteoporosis
About this trial
This is an interventional supportive care trial for Breast Cancer focused on measuring osteoporosis, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer
Eligibility Criteria
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
Sites / Locations
- Mobile Infirmary Medical Center
- Mayo Clinic Scottsdale
- Aurora Presbyterian Hospital
- Boulder Community Hospital
- Penrose Cancer Center at Penrose Hospital
- Porter Adventist Hospital
- Presbyterian - St. Luke's Medical Center
- St. Joseph Hospital
- Rose Medical Center
- CCOP - Colorado Cancer Research Program, Incorporated
- Swedish Medical Center
- Sky Ridge Medical Center
- Hope Cancer Care Center at Longmont United Hospital
- St. Mary-Corwin Regional Medical Center
- North Suburban Medical Center
- Mayo Clinic - Jacksonville
- Piedmont Hospital
- Northside Hospital Cancer Center
- Saint Joseph's Hospital of Atlanta
- CCOP - Atlanta Regional
- MBCCOP-Medical College of Georgia Cancer Center
- WellStar Cobb Hospital
- Charles B. Eberhart Cancer Center at DeKalb Medical Center
- Gwinnett Medical Center
- Kennestone Cancer Center at Wellstar Kennestone Hospital
- Southern Regional Medical Center
- Rush-Copley Cancer Care Center
- St. Joseph Medical Center
- Graham Hospital
- Memorial Hospital
- Eureka Community Hospital
- Galesburg Clinic
- Galesburg Cottage Hospital
- InterCommunity Cancer Center of Western Illinois
- Mason District Hospital
- Hopedale Medical Complex
- Joliet Oncology Hematology Associates, Limited - West
- Kewanee Hospital
- McDonough District Hospital
- Trinity Medical Center - East
- BroMenn Regional Medical Center
- Community Cancer Center
- Community Hospital of Ottawa
- Oncology Hematology Associates of Central Illinois - Ottawa
- Cancer Treatment Center at Pekin Hospital
- Proctor Hospital
- CCOP - Illinois Oncology Research Association
- Oncology/Hematology Associates of Central Illinois, P.C.
- Methodist Medical Center of Illinois
- OSF St. Francis Medical Center
- Illinois Valley Community Hospital
- Perry Memorial Hospital
- St. Margaret's Hospital
- Valley Cancer Center
- Carle Cancer Center at Carle Foundation Hospital
- CCOP - Carle Cancer Center
- Saint Anthony Memorial Health Centers
- McFarland Clinic, P. C.
- Saint Anthony Regional Hospital
- St. Luke's Hospital
- Cedar Rapids Oncology Associates
- Mercy Regional Cancer Center at Mercy Medical Center
- Alegent Health Mercy Hospital
- Mercy Capitol Hospital
- CCOP - Iowa Oncology Research Association
- John Stoddard Cancer Center at Iowa Methodist Medical Center
- Medical Oncology and Hematology Associates at John Stoddard Cancer Center
- Medical Oncology and Hematology Associates at Mercy Cancer Center
- Mercy Cancer Center at Mercy Medical Center - Des Moines
- John Stoddard Cancer Center at Iowa Lutheran Hospital
- Alegent Health Community Memorial Hospital
- Burgess Health Center
- Ottumwa Regional Health Center Cancer Center
- Siouxland Hematology-Oncology Associates at June E. Nylen Cancer Center
- Siouxland Regional Cancer Center
- Mercy Medical Center - Sioux City
- St. Luke's Regional Medical Center
- Medical Oncology and Hematology Associates - West Des Moines
- Cancer Center of Kansas, P.A. - Chanute
- Cancer Center of Kansas, P.A. - Dodge City
- Cancer Center of Kansas, P.A. - El Dorado
- Cancer Center of Kansas, P.A. - Kingman
- Southwest Medical Center
- Cancer Center of Kansas, P.A. - Newton
- Cancer Center of Kansas, P.A. - Parsons
- Cancer Center of Kansas, P.A. - Pratt
- Cancer Center of Kansas, P.A. - Salina
- Cancer Center of Kansas, P.A. - Wellington
- Associates in Womens Health, P.A. - North Review
- Cancer Center of Kansas, P.A. - Medical Arts Tower
- Cancer Center of Kansas, P.A. - Wichita
- CCOP - Wichita
- Via Christi Cancer Center at Via Christi Regional Medical Center
- Cancer Center of Kansas, P.A. - Winfield
- Ochsner Clinic of Baton Rouge
- Terrebonne General Medical Center
- CCOP - Ochsner
- Ochsner Cancer Institute at Ochsner Clinic Foundation
- Hickman Cancer Center at Bixby Medical Center
- St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital
- CCOP - Michigan Cancer Research Consortium
- Green Bay Oncology, Limited - Escanaba
- Green Bay Oncology, Limited - Iron Mountain
- Haematology-Oncology Associates of Ohio and Michigan, P.C.
- Community Cancer Center of Monroe
- Mercy Memorial Hospital System
- MeritCare Clinic - Bemidji
- Fairview Ridges Hospital
- Mercy and Unity Cancer Center at Mercy Hospital
- CCOP - Duluth
- Miller-Dwan Medical Center
- St. Mary's - Duluth Clinic Cancer Center
- Fairview Southdale Hospital
- Mercy and Unity Cancer Center at Unity Hospital
- Immanuel St. Joseph's Clinic
- Virginia Piper Cancer Institute at Abbott-Northwestern Hospital
- Hubert H. Humphrey Cancer Center at North Memorial Medical Center
- Mayo Clinic Cancer Center
- CCOP - Metro-Minnesota
- Park Nicollet Health Services
- United Hospital
- Ridgeview Medical Center
- Hattiesburg Clinic, P.A.
- CCOP - Montana Cancer Consortium
- Hematology-Oncology Centers of the Northern Rockies - Billings
- Northern Rockies Radiation Oncology Center
- St. Vincent Healthcare
- Deaconess Billings Clinic Cancer Center
- Deaconess Billings Clinic - Downtown
- Bozeman Deaconess Hospital
- Internal Medicine Associates of Bozeman
- St. James Community Hospital
- Great Falls Clinic
- St. Peter's Hospital
- Glacier Oncology, PLLC
- Kalispell Medical Oncology
- Eastern Montana Cancer Center
- Community Medical Center
- Montana Cancer Specialists at Montana Cancer Center
- Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
- Bryan LGH Medical Center West
- Cancer Resource Center - Lincoln
- St. Elizabeth Regional Medical Center
- CCOP - Missouri Valley Cancer Consortium
- Immanuel Medical Center
- Bergan Mercy Medical Center
- Creighton University Medical Center
- Midlands Cancer Center at Midlands Community Hospital
- Rutherford Hospital
- Bismarck Cancer Center
- Cancer Care Center at Medcenter One Hospital
- Mid Dakota Clinic, P. C.
- St. Alexius Medical Center
- CCOP - MeritCare Hospital
- MeritCare Medical Group
- Altru Cancer Center at Altru Hospital
- Wood County Oncology Center
- Blanchard Valley Medical Associates
- Fremont Memorial Hospital
- Kenton Oncology, Incorporated
- Lima Memorial Hospital
- Northwest Ohio Oncology Center
- St. Luke's Hospital
- St. Charles Mercy Hospital
- Toledo Clinic - Oregon
- Firelands Regional Medical Center
- North Coast Cancer Care, Incorporated
- Promedica Cancer Center at Flower Hospital
- Mercy Hospital of Tiffin
- Toledo Hospital
- St. Vincent Mercy Medical Center
- Medical College of Ohio Cancer Institute
- CCOP - Toledo Community Hospital
- Toledo Clinic, Incorporated - Main Clinic
- Toledo Surgical Specialists
- Fulton County Health Center
- Natalie Warren Bryant Cancer Center at St. Francis Hospital
- Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
- Geisinger Medical Center
- Geisinger Medical Group
- Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
- Rose Ramer Cancer Clinic at Anderson Area Medical Center
- CCOP - Upstate Carolina
- Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
- Rapid City Regional Hospital
- Avera McKennan Hospital and University Health Center
- Medical X-Ray Center, P. C.
- Sioux Valley Hospital and University of South Dakota Medical Center
- Green Bay Oncology, Limited at St. Vincent Hospital
- Green Bay Oncology, Limited at St. Mary's Hospital
- St. Mary's Hospital Medical Center - Green Bay
- St. Vincent Hospital Regional Cancer Center
- Green Bay Oncology, Limited - Oconto Falls
- Green Bay Oncology, Limited - Sturgeon Bay
- Welch Cancer Center at Sheridan Memorial Hospital
- Allan Blair Cancer Centre at Pasqua Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
calcium carbonate, vitamin D and risedronate
calcium carbonate, vitamin D and placebo
Patients receive calcium carbonate 600 mg daily, vitamin D 400 U daily and risedronate 35 mg weekly.
Patients receive calcium carbonate 600 mg daily, vitamin D 400 U daily and placebo weekly.