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
Not Enrolling
Female
Breast Cancer, Osteoporosis

Thank you

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