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
Phase 3
18 Years
N/A
18 Years
N/A
Not Enrolling
Female
Breast Cancer, Osteoporosis
Female
Breast Cancer, Osteoporosis
Trial Information
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
OBJECTIVES:
- Compare the effectiveness of risedronate vs placebo in the prevention of bone loss in
premenopausal women undergoing adjuvant or neoadjuvant chemotherapy for primary breast
cancer.
- Compare the degree of bone loss over 1 year in these women according to menopausal
status after 1 year of therapy.
- Determine the relationship of current climacteric symptoms, menstrual and reproductive
history, and chemotherapy regimen with ovarian failure (permanent cessation of menses)
in these women.
- Determine the relationship of baseline serum estradiol levels with ovarian failure in
these women.
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.
- Arm I: Patients receive oral calcium and oral cholecalciferol daily and oral
risedronate once weekly.
- Arm II: Patients receive calcium and cholecalciferol as in arm I and oral placebo once
weekly.
In both arms, treatment begins during the first month of chemotherapy and continues for 1
year in the absence of unacceptable toxicity.
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.
PROJECTED ACCRUAL: A total of 220 patients (110 per treatment arm) will be accrued for this
study within 11 months.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Resectable primary breast cancer
- Stage I-IIIB disease
- Scheduled to undergo adjuvant or neoadjuvant chemotherapy
- No hypercalcemia (calcium level greater than 1 mg/dL above upper limit of normal
within the past 6 months)
- No hypocalcemia (calcium level greater than 0.5 mg/dL below lower limit of normal
within the past 6 months)
- No diseases affecting bone metabolism (i.e., hyperparathyroidism, hyperthyroidism,
and hypercortisolism)
- Bone mineral density T score of -2.0 or greater at the hip or spine (T score of -2.1
or less is ineligible)
PATIENT CHARACTERISTICS:
Age
- 18 and over
Sex
- Female
Menopausal status
- Premenopausal meeting the following criteria:
- No more than 6 months since last menstrual period
- No prior bilateral oophorectomy
- Not on estrogen replacement therapy
- If total abdominal hysterectomy performed, then must have at least 1 intact
ovary
- If more than 3 months since last menstrual period, then must have
premenopausal estrogen levels within 1 month of study entry
Performance status
- ECOG 0-1
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Not specified
Renal
- Creatinine no greater than 2.0 mg/dL
- No history of severe renal impairment
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective barrier contraception
- Able to stand or sit upright for at least 30 minutes
- No known swallowing disorder
- No history of vertebral compression fracture
- Traumatic fracture of the coccyx allowed
- No malabsorption syndrome
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- See Disease Characteristics
Endocrine therapy
- No concurrent estrogen
- No concurrent estrogen receptor modulators except tamoxifen
- No corticosteroid dose of prednisone or equivalent greater than 5 mg daily for more
than 2 weeks within the past 6 months
- No concurrent estrogen replacement therapy
- No concurrent oral contraceptives
Radiotherapy
- Not specified
Surgery
- More than 3 months since prior and no concurrent dental extraction, root canal, or
dental implants
- No prior bilateral oophorectomy
Other
- No prior bisphosphonates
- No other concurrent bisphosphonates
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care
Outcome Measure:
Average intra-patient change in lumbar spine (L2-L4, PA) bone mineral density (BMD) from baseline to one year after study entry
Principal Investigator
Stephanie Hines, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Mayo Clinic
Authority:
United States: Federal Government
Study ID:
CDR0000270449
NCT ID:
NCT00054418
Start Date:
March 2003
Completion Date:
Related Keywords:
- Breast Cancer
- Osteoporosis
- osteoporosis
- stage I breast cancer
- stage II breast cancer
- stage IIIA breast cancer
- stage IIIB breast cancer
- Breast Neoplasms
- Osteoporosis
Name | Location |
|---|---|
| Mayo Clinic Scottsdale | Scottsdale, Arizona 85259 |
| Mayo Clinic - Jacksonville | Jacksonville, Florida 32224 |
| Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
| CCOP - Upstate Carolina | Spartanburg, South Carolina 29303 |
| CCOP - Wichita | Wichita, Kansas 67214-3882 |
| CCOP - Atlanta Regional | Atlanta, Georgia 30342-1701 |
| CCOP - Missouri Valley Cancer Consortium | Omaha, Nebraska 68131 |
| CCOP - Illinois Oncology Research Association | Peoria, Illinois 61602 |
| CCOP - Carle Cancer Center | Urbana, Illinois 61801 |
| CCOP - Iowa Oncology Research Association | Des Moines, Iowa 50309-1016 |
| CCOP - Metro-Minnesota | Saint Louis Park, Minnesota 55416 |
| Bergan Mercy Medical Center | Omaha, Nebraska 68124 |
| Aurora Presbyterian Hospital | Aurora, Colorado 80012 |
| Boulder Community Hospital | Boulder, Colorado 80301-9019 |
| Penrose Cancer Center at Penrose Hospital | Colorado Springs, Colorado 80933 |
| Porter Adventist Hospital | Denver, Colorado 80210 |
| Presbyterian - St. Luke's Medical Center | Denver, Colorado 80218 |
| St. Joseph Hospital | Denver, Colorado 80218 |
| Rose Medical Center | Denver, Colorado 80220 |
| Swedish Medical Center | Englewood, Colorado 80110 |
| Sky Ridge Medical Center | Lone Tree, Colorado 80124 |
| Hope Cancer Care Center at Longmont United Hospital | Longmont, Colorado 80502 |
| North Suburban Medical Center | Thornton, Colorado 80229 |
| Rush-Copley Cancer Care Center | Aurora, Illinois 60507 |
| Carle Cancer Center at Carle Foundation Hospital | Urbana, Illinois 61801 |
| Saint Anthony Memorial Health Centers | Michigan City, Indiana 46360 |
| Cedar Rapids Oncology Associates | Cedar Rapids, Iowa 52403 |
| Mercy Medical Center - Sioux City | Sioux City, Iowa 51104 |
| St. Luke's Regional Medical Center | Sioux City, Iowa 51104 |
| CCOP - Michigan Cancer Research Consortium | Ann Arbor, Michigan 48106 |
| Fairview Ridges Hospital | Burnsville, Minnesota 55337 |
| Mercy and Unity Cancer Center at Mercy Hospital | Coon Rapids, Minnesota 55433 |
| CCOP - Duluth | Duluth, Minnesota 55805 |
| Fairview Southdale Hospital | Edina, Minnesota 55435 |
| Mercy and Unity Cancer Center at Unity Hospital | Fridley, Minnesota 55432 |
| United Hospital | St. Paul, Minnesota 55102 |
| Ridgeview Medical Center | Waconia, Minnesota 55387 |
| CCOP - MeritCare Hospital | Fargo, North Dakota 58122 |
| Natalie Warren Bryant Cancer Center at St. Francis Hospital | Tulsa, Oklahoma 74136 |
| Geisinger Medical Center | Danville, Pennsylvania 17822-0001 |
| Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center | Wilkes-Barre, Pennsylvania 18711 |
| CCOP - Ochsner | New Orleans, Louisiana 70121 |
| Rapid City Regional Hospital | Rapid City, South Dakota 57709 |
| Methodist Medical Center of Illinois | Peoria, Illinois 61636 |
| CCOP - Montana Cancer Consortium | Billings, Montana 59101 |
| Hinsdale, Illinois 60521 | |
| Mobile Infirmary Medical Center | Mobile, Alabama 36640-0460 |
| John Stoddard Cancer Center at Iowa Methodist Medical Center | Des Moines, Iowa 50309 |
| Midlands Cancer Center at Midlands Community Hospital | Papillion, Nebraska 68128-4157 |
| St. Vincent Mercy Medical Center | Toledo, Ohio 43608 |
| CCOP - Colorado Cancer Research Program, Incorporated | Denver, Colorado 80224 |
| Great Falls Clinic | Great Falls, Montana 59405 |
| Northside Hospital Cancer Center | Atlanta, Georgia 30342-1611 |
| Sioux Valley Hospital and University of South Dakota Medical Center | Sioux Falls, South Dakota 57117-5134 |
| CCOP - Toledo Community Hospital | Toledo, Ohio 43623-3456 |
| Via Christi Cancer Center at Via Christi Regional Medical Center | Wichita, Kansas 67214 |
| Ochsner Cancer Institute at Ochsner Clinic Foundation | New Orleans, Louisiana 70121 |
| Toledo Hospital | Toledo, Ohio 43606 |
| St. Vincent Hospital Regional Cancer Center | Green Bay, Wisconsin 54307-3508 |
| St. Mary's - Duluth Clinic Cancer Center | Duluth, Minnesota 55805 |
| Green Bay Oncology, Limited - Escanaba | Escanaba, Michigan 49431 |
| St. Mary's Hospital Medical Center - Green Bay | Green Bay, Wisconsin 54303 |
| Green Bay Oncology, Limited at St. Mary's Hospital | Green Bay, Wisconsin 54303 |
| Green Bay Oncology, Limited - Oconto Falls | Oconto Falls, Wisconsin 54154 |
| Green Bay Oncology, Limited - Sturgeon Bay | Sturgeon Bay, Wisconsin 54235 |
| Siouxland Regional Cancer Center | Sioux City, Iowa 51101-1733 |
| Cancer Center of Kansas, P.A. - El Dorado | El Dorado, Kansas 67042 |
| Southwest Medical Center | Liberal, Kansas 67901 |
| Cancer Center of Kansas, P.A. - Parsons | Parsons, Kansas 67357 |
| Cancer Center of Kansas, P.A. - Wichita | Wichita, Kansas 67214 |
| Northern Rockies Radiation Oncology Center | Billings, Montana 59101 |
| Hematology-Oncology Centers of the Northern Rockies - Billings | Billings, Montana 59101 |
| St. Vincent Healthcare | Billings, Montana 59101 |
| Deaconess Billings Clinic - Downtown | Billings, Montana 59101 |
| Deaconess Billings Clinic Cancer Center | Billings, Montana 59107 |
| Internal Medicine Associates of Bozeman | Bozeman, Montana 59715 |
| Bozeman Deaconess Hospital | Bozeman, Montana 59715 |
| St. James Community Hospital | Butte, Montana 59701 |
| St. Peter's Hospital | Helena, Montana 59601 |
| Kalispell Medical Oncology | Kalispell, Montana 59901 |
| Glacier Oncology, PLLC | Kalispell, Montana 59901 |
| Eastern Montana Cancer Center | Miles City, Montana 59301 |
| Montana Cancer Center at St. Patrick Hospital and Health Sciences Center | Missoula, Montana 59802 |
| Montana Cancer Specialists at Montana Cancer Center | Missoula, Montana 59802 |
| Community Medical Center | Missoula, Montana 59801 |
| Avera McKennan Hospital and University Health Center | Sioux Falls, South Dakota 57105 |
| MBCCOP-Medical College of Georgia Cancer Center | Augusta, Georgia 30912-4000 |
| Oncology/Hematology Associates of Central Illinois, P.C. | Peoria, Illinois 61602 |
| Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest | Allentown, Pennsylvania 18105 |
| St. Mary-Corwin Regional Medical Center | Pueblo, Colorado 81004 |
| Saint Joseph's Hospital of Atlanta | Atlanta, Georgia 30342-1701 |
| Piedmont Hospital | Atlanta, Georgia 30309 |
| WellStar Cobb Hospital | Austell, Georgia 30106 |
| Charles B. Eberhart Cancer Center at DeKalb Medical Center | Decatur, Georgia 30033 |
| Gwinnett Medical Center | Lawrenceville, Georgia 30045 |
| Kennestone Cancer Center at Wellstar Kennestone Hospital | Marietta, Georgia 30060 |
| Southern Regional Medical Center | Riverdale, Georgia 30274-2600 |
| St. Joseph Medical Center | Bloomington, Illinois 61701 |
| Graham Hospital | Canton, Illinois 61520 |
| Memorial Hospital | Carthage, Illinois 62321 |
| Eureka Community Hospital | Eureka, Illinois 61530 |
| Galesburg Cottage Hospital | Galesburg, Illinois 61401 |
| Galesburg Clinic | Galesburg, Illinois 61401 |
| InterCommunity Cancer Center of Western Illinois | Galesburg, Illinois 61401 |
| Mason District Hospital | Havana, Illinois 62644 |
| Hopedale Medical Complex | Hopedale, Illinois 61747 |
| Kewanee Hospital | Kewanee, Illinois 61443 |
| McDonough District Hospital | Macomb, Illinois 61455 |
| Trinity Medical Center - East | Moline, Illinois 61265 |
| BroMenn Regional Medical Center | Normal, Illinois 61761 |
| Community Cancer Center | Normal, Illinois 61761 |
| Community Hospital of Ottawa | Ottawa, Illinois 61350 |
| Cancer Treatment Center at Pekin Hospital | Pekin, Illinois 61554 |
| OSF St. Francis Medical Center | Peoria, Illinois 61637 |
| Proctor Hospital | Peoria, Illinois 61614 |
| Illinois Valley Community Hospital | Peru, Illinois 61354 |
| Perry Memorial Hospital | Princeton, Illinois 61356 |
| St. Margaret's Hospital | Spring Valley, Illinois 61362 |
| Valley Cancer Center | Spring Valley, Illinois 61362 |
| McFarland Clinic, P. C. | Ames, Iowa 50010 |
| Bettendorf, Iowa 52722 | |
| St. Luke's Hospital | Cedar Rapids, Iowa 52402 |
| Mercy Regional Cancer Center at Mercy Medical Center | Cedar Rapids, Iowa 52403 |
| John Stoddard Cancer Center at Iowa Lutheran Hospital | Des Moines, Iowa 50316-2301 |
| Mercy Capitol Hospital | Des Moines, Iowa 50307 |
| Medical Oncology and Hematology Associates at John Stoddard Cancer Center | Des Moines, Iowa 50309 |
| Medical Oncology and Hematology Associates at Mercy Cancer Center | Des Moines, Iowa 50314 |
| Mercy Cancer Center at Mercy Medical Center - Des Moines | Des Moines, Iowa 50314 |
| Burgess Health Center | Onawa, Iowa 51040 |
| Medical Oncology and Hematology Associates - West Des Moines | West Des Moines, Iowa 50266 |
| Cancer Center of Kansas, P.A. - Chanute | Chanute, Kansas 66720 |
| Cancer Center of Kansas, P.A. - Kingman | Kingman, Kansas 67068 |
| Cancer Center of Kansas, P.A. - Newton | Newton, Kansas 67114 |
| Cancer Center of Kansas, P.A. - Pratt | Pratt, Kansas 67124 |
| Cancer Center of Kansas, P.A. - Salina | Salina, Kansas 67042 |
| Cancer Center of Kansas, P.A. - Wellington | Wellington, Kansas 67152 |
| Cancer Center of Kansas, P.A. - Medical Arts Tower | Wichita, Kansas 67208 |
| Associates in Womens Health, P.A. - North Review | Wichita, Kansas 67203 |
| Cancer Center of Kansas, P.A. - Winfield | Winfield, Kansas 67156 |
| Ochsner Clinic of Baton Rouge | Baton Rouge, Louisiana 708169990 |
| Terrebonne General Medical Center | Houma, Louisiana 70360 |
| Hickman Cancer Center at Bixby Medical Center | Adrian, Michigan 49221 |
| St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital | Ann Arbor, Michigan 48106-0995 |
| Green Bay Oncology, Limited - Iron Mountain | Iron Mountain, Michigan 49801 |
| Haematology-Oncology Associates of Ohio and Michigan, P.C. | Lambertville, Michigan 48144 |
| Community Cancer Center of Monroe | Monroe, Michigan 48162 |
| Mercy Memorial Hospital System | Monroe, Michigan 48162 |
| MeritCare Clinic - Bemidji | Bemidji, Minnesota 56601 |
| Virginia Piper Cancer Institute at Abbott-Northwestern Hospital | Minneapolis, Minnesota 55407 |
| Hubert H. Humphrey Cancer Center at North Memorial Medical Center | Robbinsdale, Minnesota 55422-2900 |
| Park Nicollet Health Services | St. Louis Park, Minnesota 55416 |
| Hattiesburg Clinic, P.A. | Hattiesburg, Mississippi 39401 |
| Bryan LGH Medical Center West | Lincoln, Nebraska 68502 |
| St. Elizabeth Regional Medical Center | Lincoln, Nebraska 68510 |
| Immanuel Medical Center | Omaha, Nebraska 68122 |
| Creighton University Medical Center | Omaha, Nebraska 68131-2197 |
| Cancer Care Center at Medcenter One Hospital | Bismarck, North Dakota 58501 |
| Bismarck Cancer Center | Bismarck, North Dakota 58501 |
| St. Alexius Medical Center | Bismarck, North Dakota 58502 |
| Mid Dakota Clinic, P. C. | Bismarck, North Dakota 58501 |
| MeritCare Medical Group | Fargo, North Dakota 58122 |
| Wood County Oncology Center | Bowling Green, Ohio 43402 |
| Blanchard Valley Medical Associates | Findlay, Ohio 45840 |
| Fremont Memorial Hospital | Fremont, Ohio 43420 |
| Kenton Oncology, Incorporated | Kenton, Ohio 43326 |
| Lima Memorial Hospital | Lima, Ohio 45804 |
| St. Luke's Hospital | Maumee, Ohio 43537 |
| Northwest Ohio Oncology Center | Maumee, Ohio 43537 |
| Toledo Clinic - Oregon | Oregon, Ohio 43616 |
| St. Charles Mercy Hospital | Oregon, Ohio 43616 |
| North Coast Cancer Care, Incorporated | Sandusky, Ohio 44870 |
| Firelands Regional Medical Center | Sandusky, Ohio 44870 |
| Promedica Cancer Center at Flower Hospital | Sylvania, Ohio 43560 |
| Mercy Hospital of Tiffin | Tiffin, Ohio 44883 |
| Toledo Clinic, Incorporated - Main Clinic | Toledo, Ohio 43623 |
| Toledo Surgical Specialists | Toledo, Ohio 43623 |
| Fulton County Health Center | Wauseon, Ohio 43567 |
| Green Bay Oncology, Limited at St. Vincent Hospital | Green Bay, Wisconsin 54301-3526 |
| Welch Cancer Center at Sheridan Memorial Hospital | Sheridan, Wyoming 82801 |
| Joliet Oncology Hematology Associates, Limited - West | Joliet, Illinois 60435 |
| Oncology Hematology Associates of Central Illinois - Ottawa | Ottawa, Illinois 61350 |
| Rose Ramer Cancer Clinic at Anderson Area Medical Center | Anderson, South Carolina 29621 |
| Saint Anthony Regional Hospital | Carroll, Iowa 51401 |
| Miller-Dwan Medical Center | Duluth, Minnesota 55805 |
| Geisinger Medical Group | State College, Pennsylvania 16801 |
| Alegent Health Mercy Hospital | Council Bluffs, Iowa 51503 |
| Alegent Health Community Memorial Hospital | Missouri Valley, Iowa 51555 |
| Cancer Resource Center - Lincoln | Lincoln, Nebraska 68510 |
| Altru Cancer Center at Altru Hospital | Grand Forks, North Dakota 58201 |
| Medical College of Ohio Cancer Institute | Toledo, Ohio 43614 |
| Immanuel St. Joseph's Clinic | Mankato, Minnesota 56002 |
| Rutherford Hospital | Rutherfordton, North Carolina 28139 |
| Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | Spartanburg, South Carolina 29303 |
| Cancer Center of Kansas, P.A. - Dodge City | Dodge City, Kansas 67801 |
| Miami, Florida 33176 | |
| Siouxland Hematology-Oncology Associates at June E. Nylen Cancer Center | Sioux City, Iowa 51101 |
| Ottumwa Regional Health Center Cancer Center | Ottumwa, Iowa 52501 |
| Medical X-Ray Center, P. C. | Sioux Falls, South Dakota 57105 |
