Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Risedronate in Preventing Bone Loss in Premenopausal Women Receiving Chemotherapy for Primary Breast Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00054418
First received: February 5, 2003
Last updated: November 12, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Osteoporosis
Dietary Supplement: calcium carbonate
Dietary Supplement: vitamin D
Drug: risedronate sodium
Other: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
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

Resource links provided by NLM:


Further study details as provided by Alliance for Clinical Trials in Oncology:

Primary Outcome Measures:
  • Average intra-patient change in lumbar spine (L2-L4, PA) bone mineral density (BMD) from baseline to one year after study entry [ Time Frame: 1 year post study entry ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Average intra-patient change in femoral neck and total hip BMD from baseline to one year after study entry [ Time Frame: 1 year post study entry ] [ Designated as safety issue: No ]
  • Incidence of osteopenia in the risedronate vs placebo groups at one year after study entry [ Time Frame: 1 year post study entry ] [ Designated as safety issue: No ]
  • Incidence of osteoporosis in the risedronate vs placebo groups at one year after study entry [ Time Frame: 1 year post study entry ] [ Designated as safety issue: No ]
  • Incidence of a 5% difference in intra-patient BMD scores at baseline [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Serum and urine N-telopeptide and serum alkaline phosphatase at baseline and 6 months [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
  • Frequency and severity of toxicity as measured by NCI CTC version 2.0 [ Time Frame: Up to 1 year post study treatment ] [ Designated as safety issue: Yes ]
  • Menopausal symptoms as measured by the Greene Climacteric Scale (GCS) at baseline, monthly during chemotherapy, at 6 months, 1 year, and 2 years after study entry [ Time Frame: Up to 2 years post study entry ] [ Designated as safety issue: No ]
  • Association of baseline serum estradiol levels with permanent cessation of menses [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Relationship between the subscales of the GCS (psychological, vasomotor, somatic and sexual) with type of chemotherapy, duration of chemotherapy, and menstrual cycle changes [ Time Frame: Up to 2 years post study entry ] [ Designated as safety issue: No ]

Enrollment: 216
Study Start Date: March 2003
Study Completion Date: May 2008
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: calcium carbonate, vitamin D and risedronate
Patients receive calcium carbonate 600 mg daily, vitamin D 400 U daily and risedronate 35 mg weekly.
Dietary Supplement: calcium carbonate
calcium 600 mg daily administered orally for one year
Dietary Supplement: vitamin D
vitamin D 400 U daily administered orally for one year
Drug: risedronate sodium
risedronate 35 mg weekly administered orally
Placebo Comparator: calcium carbonate, vitamin D and placebo
Patients receive calcium carbonate 600 mg daily, vitamin D 400 U daily and placebo weekly.
Dietary Supplement: calcium carbonate
calcium 600 mg daily administered orally for one year
Dietary Supplement: vitamin D
vitamin D 400 U daily administered orally for one year
Other: placebo
placebo tablet weekly administered orally for one year

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria
  1. Required Characteristics

    1. 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
    2. Scheduled to undergo adjuvant or neoadjuvant chemotherapy for primary breast cancer (stages I-IIIB)
    3. ≥ 18 years of age
    4. ECOG performance status (PS) 0 or 1
  2. Contraindications

    1. Hypercalcemia (calcium level > 1mg/dL above UNL ≤ 6 months
    2. Hypocalcemia (calcium level > 0.5 mg/dL below UNL ≤ 6 months
    3. Inability to stand or sit upright for at least 30 minutes
    4. Known swallowing disorder
    5. 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
    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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00054418

  Hide Study Locations
Locations
United States, Alabama
Mobile Infirmary Medical Center
Mobile, Alabama, United States, 36652-2144
United States, Arizona
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States, 85259
United States, Colorado
Aurora Presbyterian Hospital
Aurora, Colorado, United States, 80012
Boulder Community Hospital
Boulder, Colorado, United States, 80301-9019
Penrose Cancer Center at Penrose Hospital
Colorado Springs, Colorado, United States, 80933
CCOP - Colorado Cancer Research Program, Incorporated
Denver, Colorado, United States, 80224-2522
Porter Adventist Hospital
Denver, Colorado, United States, 80210
Presbyterian - St. Luke's Medical Center
Denver, Colorado, United States, 80218
Rose Medical Center
Denver, Colorado, United States, 80220
St. Joseph Hospital
Denver, Colorado, United States, 80218
Swedish Medical Center
Englewood, Colorado, United States, 80110
Sky Ridge Medical Center
Lone Tree, Colorado, United States, 80124
Hope Cancer Care Center at Longmont United Hospital
Longmont, Colorado, United States, 80502
St. Mary-Corwin Regional Medical Center
Pueblo, Colorado, United States, 81004
North Suburban Medical Center
Thorton, Colorado, United States, 80229
United States, Florida
Gainesville, Florida, United States, 32605
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States, 32224
United States, Georgia
CCOP - Atlanta Regional
Atlanta, Georgia, United States, 30342
Northside Hospital Cancer Center
Atlanta, Georgia, United States, 30342-1611
Piedmont Hospital
Atlanta, Georgia, United States, 30309
Saint Joseph's Hospital of Atlanta
Atlanta, Georgia, United States, 30342-1701
MBCCOP-Medical College of Georgia Cancer Center
Augusta, Georgia, United States, 30912
WellStar Cobb Hospital
Austell, Georgia, United States, 30106
Charles B. Eberhart Cancer Center at DeKalb Medical Center
Decatur, Georgia, United States, 30033
Gwinnett Medical Center
Lawrenceville, Georgia, United States, 30045
Kennestone Cancer Center at Wellstar Kennestone Hospital
Marietta, Georgia, United States, 30060
Southern Regional Medical Center
Riverdale, Georgia, United States, 30274-2600
United States, Illinois
Rush-Copley Cancer Care Center
Aurora, Illinois, United States, 60507
St. Joseph Medical Center
Bloomington, Illinois, United States, 61701
Graham Hospital
Canton, Illinois, United States, 61520
Memorial Hospital
Carthage, Illinois, United States, 62321
Eureka Community Hospital
Eureka, Illinois, United States, 61530
Galesburg Clinic
Galesburg, Illinois, United States, 61401
Galesburg Cottage Hospital
Galesburg, Illinois, United States, 61401
InterCommunity Cancer Center of Western Illinois
Galesburg, Illinois, United States, 61401
Mason District Hospital
Havana, Illinois, United States, 62644
Hopedale Medical Complex
Hopedale, Illinois, United States, 61747
Joliet Oncology Hematology Associates, Limited - West
Joliet, Illinois, United States, 60435
Kewanee Hospital
Kewanee, Illinois, United States, 61443
McDonough District Hospital
Macomb, Illinois, United States, 61455
Moline, Illinois, United States, 61265
Trinity Medical Center - East
Moline, Illinois, United States, 61265
BroMenn Regional Medical Center
Normal, Illinois, United States, 61761
Community Cancer Center
Normal, Illinois, United States, 61761
Community Hospital of Ottawa
Ottawa, Illinois, United States, 61350
Oncology Hematology Associates of Central Illinois - Ottawa
Ottawa, Illinois, United States, 61350
Cancer Treatment Center at Pekin Hospital
Pekin, Illinois, United States, 61554
Methodist Medical Center of Illinois
Peoria, Illinois, United States, 61636
CCOP - Illinois Oncology Research Association
Peoria, Illinois, United States, 61615
Oncology/Hematology Associates of Central Illinois, P.C.
Peoria, Illinois, United States, 61615
OSF St. Francis Medical Center
Peoria, Illinois, United States, 61637
Proctor Hospital
Peoria, Illinois, United States, 61614
Illinois Valley Community Hospital
Peru, Illinois, United States, 61354
Perry Memorial Hospital
Princeton, Illinois, United States, 61356
St. Margaret's Hospital
Spring Valley, Illinois, United States, 61362
Valley Cancer Center
Spring Valley, Illinois, United States, 61362
CCOP - Carle Cancer Center
Urbana, Illinois, United States, 61801
Carle Cancer Center at Carle Foundation Hospital
Urbana, Illinois, United States, 61801
United States, Indiana
Saint Anthony Memorial Health Centers
Michigan City, Indiana, United States, 46360
United States, Iowa
McFarland Clinic, P. C.
Ames, Iowa, United States, 50010
Bettendorf, Iowa, United States, 52722
Saint Anthony Regional Hospital
Carroll, Iowa, United States, 51401
Cedar Rapids Oncology Associates
Cedar Rapids, Iowa, United States, 52403
Mercy Regional Cancer Center at Mercy Medical Center
Cedar Rapids, Iowa, United States, 52403
St. Luke's Hospital
Cedar Rapids, Iowa, United States, 52402
Alegent Health Mercy Hospital
Council Bluffs, Iowa, United States, 51503
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, United States, 50309
John Stoddard Cancer Center at Iowa Lutheran Hospital
Des Moines, Iowa, United States, 50316-2301
Mercy Capitol Hospital
Des Moines, Iowa, United States, 50307
Medical Oncology and Hematology Associates at John Stoddard Cancer Center
Des Moines, Iowa, United States, 50309
Medical Oncology and Hematology Associates at Mercy Cancer Center
Des Moines, Iowa, United States, 50314
Mercy Cancer Center at Mercy Medical Center - Des Moines
Des Moines, Iowa, United States, 50314
John Stoddard Cancer Center at Iowa Methodist Medical Center
Des Moines, Iowa, United States, 50309
Alegent Health Community Memorial Hospital
Missouri Valley, Iowa, United States, 51555-1199
Burgess Health Center
Onawa, Iowa, United States, 51040
Ottumwa Regional Health Center Cancer Center
Ottumwa, Iowa, United States, 52501
Mercy Medical Center - Sioux City
Sioux City, Iowa, United States, 51104
Siouxland Hematology-Oncology Associates at June E. Nylen Cancer Center
Sioux City, Iowa, United States, 51101
Siouxland Regional Cancer Center
Sioux City, Iowa, United States, 51101
St. Luke's Regional Medical Center
Sioux City, Iowa, United States, 51104
Medical Oncology and Hematology Associates - West Des Moines
West Des Moines, Iowa, United States, 50266
United States, Kansas
Cancer Center of Kansas, P.A. - Chanute
Chanute, Kansas, United States, 66720
Cancer Center of Kansas, P.A. - Dodge City
Dodge City, Kansas, United States, 67801
Cancer Center of Kansas, P.A. - El Dorado
El Dorado, Kansas, United States, 67042
Cancer Center of Kansas, P.A. - Kingman
Kingman, Kansas, United States, 67068
Southwest Medical Center
Liberal, Kansas, United States, 67901
Cancer Center of Kansas, P.A. - Newton
Newton, Kansas, United States, 67114
Cancer Center of Kansas, P.A. - Parsons
Parsons, Kansas, United States, 67357
Cancer Center of Kansas, P.A. - Pratt
Pratt, Kansas, United States, 67124
Cancer Center of Kansas, P.A. - Salina
Salina, Kansas, United States, 67042
Cancer Center of Kansas, P.A. - Wellington
Wellington, Kansas, United States, 67152
Associates in Womens Health, P.A. - North Review
Wichita, Kansas, United States, 67203
Cancer Center of Kansas, P.A. - Medical Arts Tower
Wichita, Kansas, United States, 67208
Cancer Center of Kansas, P.A. - Wichita
Wichita, Kansas, United States, 67214
CCOP - Wichita
Wichita, Kansas, United States, 67214
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita, Kansas, United States, 67214
Cancer Center of Kansas, P.A. - Winfield
Winfield, Kansas, United States, 67156
United States, Louisiana
Ochsner Clinic of Baton Rouge
Baton Rouge, Louisiana, United States, 708169990
Terrebonne General Medical Center
Houma, Louisiana, United States, 70360
CCOP - Ochsner
New Orleans, Louisiana, United States, 70121
Ochsner Cancer Institute at Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121
United States, Michigan
Hickman Cancer Center at Bixby Medical Center
Adrian, Michigan, United States, 49221
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, United States, 48106
St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital
Ann Arbor, Michigan, United States, 48106-0995
Green Bay Oncology, Limited - Escanaba
Escanaba, Michigan, United States, 49431
Green Bay Oncology, Limited - Iron Mountain
Iron Mountain, Michigan, United States, 49801
Haematology-Oncology Associates of Ohio and Michigan, P.C.
Lambertville, Michigan, United States, 48144
Community Cancer Center of Monroe
Monroe, Michigan, United States, 48162
Mercy Memorial Hospital System
Monroe, Michigan, United States, 48162
United States, Minnesota
MeritCare Clinic - Bemidji
Bemidji, Minnesota, United States, 56601
Fairview Ridges Hospital
Burnsville, Minnesota, United States, 55337
Mercy and Unity Cancer Center at Mercy Hospital
Coon Rapids, Minnesota, United States, 55433
CCOP - Duluth
Duluth, Minnesota, United States, 55805
Miller-Dwan Medical Center
Duluth, Minnesota, United States, 55805
St. Mary's - Duluth Clinic Cancer Center
Duluth, Minnesota, United States, 55805
Fairview Southdale Hospital
Edina, Minnesota, United States, 55435
Mercy and Unity Cancer Center at Unity Hospital
Fridley, Minnesota, United States, 55432
Immanuel St. Joseph's Clinic
Mankato, Minnesota, United States, 56002
Virginia Piper Cancer Institute at Abbott-Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
Hubert H. Humphrey Cancer Center at North Memorial Medical Center
Robbinsdale, Minnesota, United States, 55422-2900
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States, 55416
Park Nicollet Health Services
St. Louis Park, Minnesota, United States, 55416
United Hospital
St. Paul, Minnesota, United States, 55102
Ridgeview Medical Center
Waconia, Minnesota, United States, 55387
United States, Mississippi
Hattiesburg Clinic, P.A.
Hattiesburg, Mississippi, United States, 39401
United States, Montana
St. Vincent Healthcare
Billings, Montana, United States, 59101
CCOP - Montana Cancer Consortium
Billings, Montana, United States, 59101
Deaconess Billings Clinic - Downtown
Billings, Montana, United States, 59107-7000
Deaconess Billings Clinic Cancer Center
Billings, Montana, United States, 59107-5100
Hematology-Oncology Centers of the Northern Rockies - Billings
Billings, Montana, United States, 59101
Northern Rockies Radiation Oncology Center
Billings, Montana, United States, 59101
Bozeman Deaconess Hospital
Bozeman, Montana, United States, 59715
Internal Medicine Associates of Bozeman
Bozeman, Montana, United States, 59715
St. James Community Hospital
Butte, Montana, United States, 59701
Great Falls Clinic
Great Falls, Montana, United States, 59405
St. Peter's Hospital
Helena, Montana, United States, 59601
Glacier Oncology, PLLC
Kalispell, Montana, United States, 59901
Kalispell Medical Oncology
Kalispell, Montana, United States, 59901
Eastern Montana Cancer Center
Miles City, Montana, United States, 59301
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
Missoula, Montana, United States, 59807
Montana Cancer Specialists at Montana Cancer Center
Missoula, Montana, United States, 59807-7877
Community Medical Center
Missoula, Montana, United States, 59801
United States, Nebraska
Bryan LGH Medical Center West
Lincoln, Nebraska, United States, 68502
Cancer Resource Center - Lincoln
Lincoln, Nebraska, United States, 68510
St. Elizabeth Regional Medical Center
Lincoln, Nebraska, United States, 68510
Immanuel Medical Center
Omaha, Nebraska, United States, 68122
Bergan Mercy Medical Center
Omaha, Nebraska, United States, 68124
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, United States, 68106
Creighton University Medical Center
Omaha, Nebraska, United States, 68131-2197
Midlands Cancer Center at Midlands Community Hospital
Papillion, Nebraska, United States, 68046-4194
United States, North Carolina
Rutherford Hospital
Rutherfordton, North Carolina, United States, 28139
United States, North Dakota
Bismarck Cancer Center
Bismarck, North Dakota, United States, 58501
Cancer Care Center at Medcenter One Hospital
Bismarck, North Dakota, United States, 58501
Mid Dakota Clinic, P. C.
Bismarck, North Dakota, United States, 58501
St. Alexius Medical Center
Bismarck, North Dakota, United States, 58502
CCOP - MeritCare Hospital
Fargo, North Dakota, United States, 58122
MeritCare Medical Group
Fargo, North Dakota, United States, 58122
Altru Cancer Center at Altru Hospital
Grand Forks, North Dakota, United States, 58201
United States, Ohio
Wood County Oncology Center
Bowling Green, Ohio, United States, 43402
Blanchard Valley Medical Associates
Findlay, Ohio, United States, 45840
Fremont Memorial Hospital
Fremont, Ohio, United States, 43420
Kenton Oncology, Incorporated
Kenton, Ohio, United States, 43326
Lima Memorial Hospital
Lima, Ohio, United States, 45804
St. Luke's Hospital
Maumee, Ohio, United States, 43537
Northwest Ohio Oncology Center
Maumee, Ohio, United States, 43537
St. Charles Mercy Hospital
Oregon, Ohio, United States, 43616
Toledo Clinic - Oregon
Oregon, Ohio, United States, 43616
North Coast Cancer Care, Incorporated
Sandusky, Ohio, United States, 44870
Firelands Regional Medical Center
Sandusky, Ohio, United States, 44870
Promedica Cancer Center at Flower Hospital
Sylvania, Ohio, United States, 43560
Mercy Hospital of Tiffin
Tiffin, Ohio, United States, 44883
CCOP - Toledo Community Hospital
Toledo, Ohio, United States, 43623
Medical College of Ohio Cancer Institute
Toledo, Ohio, United States, 43614
St. Vincent Mercy Medical Center
Toledo, Ohio, United States, 43608
Toledo Surgical Specialists
Toledo, Ohio, United States, 43623
Toledo Hospital
Toledo, Ohio, United States, 43606
Toledo Clinic, Incorporated - Main Clinic
Toledo, Ohio, United States, 43623
Fulton County Health Center
Wauseon, Ohio, United States, 43567
United States, Oklahoma
Natalie Warren Bryant Cancer Center at St. Francis Hospital
Tulsa, Oklahoma, United States, 74136
United States, Pennsylvania
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
Allentown, Pennsylvania, United States, 18105
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822-0001
Geisinger Medical Group
State College, Pennsylvania, United States, 16801
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
Wilkes-Barre, Pennsylvania, United States, 18711
United States, South Carolina
Rose Ramer Cancer Clinic at Anderson Area Medical Center
Anderson, South Carolina, United States, 29621
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States, 29303
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States, 29303
United States, South Dakota
Rapid City Regional Hospital
Rapid City, South Dakota, United States, 57701
Medical X-Ray Center, P. C.
Sioux Falls, South Dakota, United States, 57105
Avera McKennan Hospital and University Health Center
Sioux Falls, South Dakota, United States, 57105-1080
Sioux Valley Hospital and University of South Dakota Medical Center
Sioux Falls, South Dakota, United States, 57117-5039
United States, Wisconsin
Green Bay Oncology, Limited at St. Mary's Hospital
Green Bay, Wisconsin, United States, 54303
Green Bay Oncology, Limited at St. Vincent Hospital
Green Bay, Wisconsin, United States, 54301-3526
St. Mary's Hospital Medical Center - Green Bay
Green Bay, Wisconsin, United States, 54303
St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, United States, 54307-3508
Green Bay Oncology, Limited - Oconto Falls
Oconto Falls, Wisconsin, United States, 54154
Green Bay Oncology, Limited - Sturgeon Bay
Sturgeon Bay, Wisconsin, United States, 54235
United States, Wyoming
Welch Cancer Center at Sheridan Memorial Hospital
Sheridan, Wyoming, United States, 82801
Canada, Saskatchewan
Allan Blair Cancer Centre at Pasqua Hospital
Regina, Saskatchewan, Canada, S4T 7T1
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
Investigators
Study Chair: Stephanie Hines, MD Mayo Clinic
  More Information

Additional Information:
Publications:
Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00054418     History of Changes
Other Study ID Numbers: NCCTG-N02C1, NCI-2012-02515, CDR0000270449
Study First Received: February 5, 2003
Last Updated: November 12, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Alliance for Clinical Trials in Oncology:
osteoporosis
stage I breast cancer
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Osteoporosis
Bone Diseases
Bone Diseases, Metabolic
Breast Diseases
Musculoskeletal Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Calcium Carbonate
Calcium, Dietary
Ergocalciferols
Etidronic Acid
Risedronic acid
Vitamin D
Vitamins
Antacids
Bone Density Conservation Agents
Calcium Channel Blockers
Cardiovascular Agents
Growth Substances
Membrane Transport Modulators
Micronutrients
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014