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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 ScottsdaleScottsdale, Arizona  85259
Mayo Clinic - JacksonvilleJacksonville, Florida  32224
Mayo Clinic Cancer CenterRochester, Minnesota  55905
CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
CCOP - WichitaWichita, Kansas  67214-3882
CCOP - Atlanta RegionalAtlanta, Georgia  30342-1701
CCOP - Missouri Valley Cancer ConsortiumOmaha, Nebraska  68131
CCOP - Illinois Oncology Research AssociationPeoria, Illinois  61602
CCOP - Carle Cancer CenterUrbana, Illinois  61801
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
Bergan Mercy Medical CenterOmaha, Nebraska  68124
Aurora Presbyterian HospitalAurora, Colorado  80012
Boulder Community HospitalBoulder, Colorado  80301-9019
Penrose Cancer Center at Penrose HospitalColorado Springs, Colorado  80933
Porter Adventist HospitalDenver, Colorado  80210
Presbyterian - St. Luke's Medical CenterDenver, Colorado  80218
St. Joseph HospitalDenver, Colorado  80218
Rose Medical CenterDenver, Colorado  80220
Swedish Medical CenterEnglewood, Colorado  80110
Sky Ridge Medical CenterLone Tree, Colorado  80124
Hope Cancer Care Center at Longmont United HospitalLongmont, Colorado  80502
North Suburban Medical CenterThornton, Colorado  80229
Rush-Copley Cancer Care CenterAurora, Illinois  60507
Carle Cancer Center at Carle Foundation HospitalUrbana, Illinois  61801
Saint Anthony Memorial Health CentersMichigan City, Indiana  46360
Cedar Rapids Oncology AssociatesCedar Rapids, Iowa  52403
Mercy Medical Center - Sioux CitySioux City, Iowa  51104
St. Luke's Regional Medical CenterSioux City, Iowa  51104
CCOP - Michigan Cancer Research ConsortiumAnn Arbor, Michigan  48106
Fairview Ridges HospitalBurnsville, Minnesota  55337
Mercy and Unity Cancer Center at Mercy HospitalCoon Rapids, Minnesota  55433
CCOP - DuluthDuluth, Minnesota  55805
Fairview Southdale HospitalEdina, Minnesota  55435
Mercy and Unity Cancer Center at Unity HospitalFridley, Minnesota  55432
United HospitalSt. Paul, Minnesota  55102
Ridgeview Medical CenterWaconia, Minnesota  55387
CCOP - MeritCare HospitalFargo, North Dakota  58122
Natalie Warren Bryant Cancer Center at St. Francis HospitalTulsa, Oklahoma  74136
Geisinger Medical CenterDanville, Pennsylvania  17822-0001
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical CenterWilkes-Barre, Pennsylvania  18711
CCOP - OchsnerNew Orleans, Louisiana  70121
Rapid City Regional HospitalRapid City, South Dakota  57709
Methodist Medical Center of IllinoisPeoria, Illinois  61636
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
Hinsdale, Illinois  60521
Mobile Infirmary Medical CenterMobile, Alabama  36640-0460
John Stoddard Cancer Center at Iowa Methodist Medical CenterDes Moines, Iowa  50309
Midlands Cancer Center at Midlands Community HospitalPapillion, Nebraska  68128-4157
St. Vincent Mercy Medical CenterToledo, Ohio  43608
CCOP - Colorado Cancer Research Program, IncorporatedDenver, Colorado  80224
Great Falls ClinicGreat Falls, Montana  59405
Northside Hospital Cancer CenterAtlanta, Georgia  30342-1611
Sioux Valley Hospital and University of South Dakota Medical CenterSioux Falls, South Dakota  57117-5134
CCOP - Toledo Community HospitalToledo, Ohio  43623-3456
Via Christi Cancer Center at Via Christi Regional Medical CenterWichita, Kansas  67214
Ochsner Cancer Institute at Ochsner Clinic FoundationNew Orleans, Louisiana  70121
Toledo HospitalToledo, Ohio  43606
St. Vincent Hospital Regional Cancer CenterGreen Bay, Wisconsin  54307-3508
St. Mary's - Duluth Clinic Cancer CenterDuluth, Minnesota  55805
Green Bay Oncology, Limited - EscanabaEscanaba, Michigan  49431
St. Mary's Hospital Medical Center - Green BayGreen Bay, Wisconsin  54303
Green Bay Oncology, Limited at St. Mary's HospitalGreen Bay, Wisconsin  54303
Green Bay Oncology, Limited - Oconto FallsOconto Falls, Wisconsin  54154
Green Bay Oncology, Limited - Sturgeon BaySturgeon Bay, Wisconsin  54235
Siouxland Regional Cancer CenterSioux City, Iowa  51101-1733
Cancer Center of Kansas, P.A. - El DoradoEl Dorado, Kansas  67042
Southwest Medical CenterLiberal, Kansas  67901
Cancer Center of Kansas, P.A. - ParsonsParsons, Kansas  67357
Cancer Center of Kansas, P.A. - WichitaWichita, Kansas  67214
Northern Rockies Radiation Oncology CenterBillings, Montana  59101
Hematology-Oncology Centers of the Northern Rockies - BillingsBillings, Montana  59101
St. Vincent HealthcareBillings, Montana  59101
Deaconess Billings Clinic - DowntownBillings, Montana  59101
Deaconess Billings Clinic Cancer CenterBillings, Montana  59107
Internal Medicine Associates of BozemanBozeman, Montana  59715
Bozeman Deaconess HospitalBozeman, Montana  59715
St. James Community HospitalButte, Montana  59701
St. Peter's HospitalHelena, Montana  59601
Kalispell Medical OncologyKalispell, Montana  59901
Glacier Oncology, PLLCKalispell, Montana  59901
Eastern Montana Cancer CenterMiles City, Montana  59301
Montana Cancer Center at St. Patrick Hospital and Health Sciences CenterMissoula, Montana  59802
Montana Cancer Specialists at Montana Cancer CenterMissoula, Montana  59802
Community Medical CenterMissoula, Montana  59801
Avera McKennan Hospital and University Health CenterSioux Falls, South Dakota  57105
MBCCOP-Medical College of Georgia Cancer CenterAugusta, Georgia  30912-4000
Oncology/Hematology Associates of Central Illinois, P.C.Peoria, Illinois  61602
Morgan Cancer Center at Lehigh Valley Hospital - Cedar CrestAllentown, Pennsylvania  18105
St. Mary-Corwin Regional Medical CenterPueblo, Colorado  81004
Saint Joseph's Hospital of AtlantaAtlanta, Georgia  30342-1701
Piedmont HospitalAtlanta, Georgia  30309
WellStar Cobb HospitalAustell, Georgia  30106
Charles B. Eberhart Cancer Center at DeKalb Medical CenterDecatur, Georgia  30033
Gwinnett Medical CenterLawrenceville, Georgia  30045
Kennestone Cancer Center at Wellstar Kennestone HospitalMarietta, Georgia  30060
Southern Regional Medical CenterRiverdale, Georgia  30274-2600
St. Joseph Medical CenterBloomington, Illinois  61701
Graham HospitalCanton, Illinois  61520
Memorial HospitalCarthage, Illinois  62321
Eureka Community HospitalEureka, Illinois  61530
Galesburg Cottage HospitalGalesburg, Illinois  61401
Galesburg ClinicGalesburg, Illinois  61401
InterCommunity Cancer Center of Western IllinoisGalesburg, Illinois  61401
Mason District HospitalHavana, Illinois  62644
Hopedale Medical ComplexHopedale, Illinois  61747
Kewanee HospitalKewanee, Illinois  61443
McDonough District HospitalMacomb, Illinois  61455
Trinity Medical Center - EastMoline, Illinois  61265
BroMenn Regional Medical CenterNormal, Illinois  61761
Community Cancer CenterNormal, Illinois  61761
Community Hospital of OttawaOttawa, Illinois  61350
Cancer Treatment Center at Pekin HospitalPekin, Illinois  61554
OSF St. Francis Medical CenterPeoria, Illinois  61637
Proctor HospitalPeoria, Illinois  61614
Illinois Valley Community HospitalPeru, Illinois  61354
Perry Memorial HospitalPrinceton, Illinois  61356
St. Margaret's HospitalSpring Valley, Illinois  61362
Valley Cancer CenterSpring Valley, Illinois  61362
McFarland Clinic, P. C.Ames, Iowa  50010
Bettendorf, Iowa  52722
St. Luke's HospitalCedar Rapids, Iowa  52402
Mercy Regional Cancer Center at Mercy Medical CenterCedar Rapids, Iowa  52403
John Stoddard Cancer Center at Iowa Lutheran HospitalDes Moines, Iowa  50316-2301
Mercy Capitol HospitalDes Moines, Iowa  50307
Medical Oncology and Hematology Associates at John Stoddard Cancer CenterDes Moines, Iowa  50309
Medical Oncology and Hematology Associates at Mercy Cancer CenterDes Moines, Iowa  50314
Mercy Cancer Center at Mercy Medical Center - Des MoinesDes Moines, Iowa  50314
Burgess Health CenterOnawa, Iowa  51040
Medical Oncology and Hematology Associates - West Des MoinesWest Des Moines, Iowa  50266
Cancer Center of Kansas, P.A. - ChanuteChanute, Kansas  66720
Cancer Center of Kansas, P.A. - KingmanKingman, Kansas  67068
Cancer Center of Kansas, P.A. - NewtonNewton, Kansas  67114
Cancer Center of Kansas, P.A. - PrattPratt, Kansas  67124
Cancer Center of Kansas, P.A. - SalinaSalina, Kansas  67042
Cancer Center of Kansas, P.A. - WellingtonWellington, Kansas  67152
Cancer Center of Kansas, P.A. - Medical Arts TowerWichita, Kansas  67208
Associates in Womens Health, P.A. - North ReviewWichita, Kansas  67203
Cancer Center of Kansas, P.A. - WinfieldWinfield, Kansas  67156
Ochsner Clinic of Baton RougeBaton Rouge, Louisiana  708169990
Terrebonne General Medical CenterHouma, Louisiana  70360
Hickman Cancer Center at Bixby Medical CenterAdrian, Michigan  49221
St. Joseph Mercy Cancer Center at St. Joseph Mercy HospitalAnn Arbor, Michigan  48106-0995
Green Bay Oncology, Limited - Iron MountainIron Mountain, Michigan  49801
Haematology-Oncology Associates of Ohio and Michigan, P.C.Lambertville, Michigan  48144
Community Cancer Center of MonroeMonroe, Michigan  48162
Mercy Memorial Hospital SystemMonroe, Michigan  48162
MeritCare Clinic - BemidjiBemidji, Minnesota  56601
Virginia Piper Cancer Institute at Abbott-Northwestern HospitalMinneapolis, Minnesota  55407
Hubert H. Humphrey Cancer Center at North Memorial Medical CenterRobbinsdale, Minnesota  55422-2900
Park Nicollet Health ServicesSt. Louis Park, Minnesota  55416
Hattiesburg Clinic, P.A.Hattiesburg, Mississippi  39401
Bryan LGH Medical Center WestLincoln, Nebraska  68502
St. Elizabeth Regional Medical CenterLincoln, Nebraska  68510
Immanuel Medical CenterOmaha, Nebraska  68122
Creighton University Medical CenterOmaha, Nebraska  68131-2197
Cancer Care Center at Medcenter One HospitalBismarck, North Dakota  58501
Bismarck Cancer CenterBismarck, North Dakota  58501
St. Alexius Medical CenterBismarck, North Dakota  58502
Mid Dakota Clinic, P. C.Bismarck, North Dakota  58501
MeritCare Medical GroupFargo, North Dakota  58122
Wood County Oncology CenterBowling Green, Ohio  43402
Blanchard Valley Medical AssociatesFindlay, Ohio  45840
Fremont Memorial HospitalFremont, Ohio  43420
Kenton Oncology, IncorporatedKenton, Ohio  43326
Lima Memorial HospitalLima, Ohio  45804
St. Luke's HospitalMaumee, Ohio  43537
Northwest Ohio Oncology CenterMaumee, Ohio  43537
Toledo Clinic - OregonOregon, Ohio  43616
St. Charles Mercy HospitalOregon, Ohio  43616
North Coast Cancer Care, IncorporatedSandusky, Ohio  44870
Firelands Regional Medical CenterSandusky, Ohio  44870
Promedica Cancer Center at Flower HospitalSylvania, Ohio  43560
Mercy Hospital of TiffinTiffin, Ohio  44883
Toledo Clinic, Incorporated - Main ClinicToledo, Ohio  43623
Toledo Surgical SpecialistsToledo, Ohio  43623
Fulton County Health CenterWauseon, Ohio  43567
Green Bay Oncology, Limited at St. Vincent HospitalGreen Bay, Wisconsin  54301-3526
Welch Cancer Center at Sheridan Memorial HospitalSheridan, Wyoming  82801
Joliet Oncology Hematology Associates, Limited - WestJoliet, Illinois  60435
Oncology Hematology Associates of Central Illinois - OttawaOttawa, Illinois  61350
Rose Ramer Cancer Clinic at Anderson Area Medical CenterAnderson, South Carolina  29621
Saint Anthony Regional HospitalCarroll, Iowa  51401
Miller-Dwan Medical CenterDuluth, Minnesota  55805
Geisinger Medical GroupState College, Pennsylvania  16801
Alegent Health Mercy HospitalCouncil Bluffs, Iowa  51503
Alegent Health Community Memorial HospitalMissouri Valley, Iowa  51555
Cancer Resource Center - LincolnLincoln, Nebraska  68510
Altru Cancer Center at Altru HospitalGrand Forks, North Dakota  58201
Medical College of Ohio Cancer InstituteToledo, Ohio  43614
Immanuel St. Joseph's ClinicMankato, Minnesota  56002
Rutherford HospitalRutherfordton, North Carolina  28139
Gibbs Regional Cancer Center at Spartanburg Regional Medical CenterSpartanburg, South Carolina  29303
Cancer Center of Kansas, P.A. - Dodge CityDodge City, Kansas  67801
Miami, Florida  33176
Siouxland Hematology-Oncology Associates at June E. Nylen Cancer CenterSioux City, Iowa  51101
Ottumwa Regional Health Center Cancer CenterOttumwa, Iowa  52501
Medical X-Ray Center, P. C.Sioux Falls, South Dakota  57105