Zoledronate in Preventing Skeletal (Bone)-Related Events in Men Who Are Receiving Androgen Deprivation Therapy For Prostate Cancer and Bone Metastases

PHASE3CompletedINTERVENTIONAL
Enrollment

645

Participants

Timeline

Start Date

January 31, 2004

Primary Completion Date

July 31, 2012

Study Completion Date

October 31, 2014

Conditions
Metastatic CancerProstate Cancer
Interventions
DRUG

zoledronic acid

Given IV

OTHER

placebo

Given IV

DRUG

androgen deprivation therapy

Patients concurrently enrolled on the Phase III study of intermittent androgen deprivation in patients with stage D2 prostate cancer will receive androgen deprivation therapy per SWOG-9346. All other patients will receive androgen deprivation therapy at a standard dose and schedule throughout the study.

DRUG

GnRH agonist

Patients concurrently enrolled on the Phase III study of intermittent androgen deprivation in patients with stage D2 prostate cancer will receive the GnRH agonist per SWOG-9346. All other patients will receive GnRH agonist at a standard dose and schedule throughout the study.

DIETARY_SUPPLEMENT

Calcium supplement

Patients will receive 500 mg by mouth daily of a calcium supplement or a combination tablet containing approximately 500 mg elemental calcium and 400-500 IU vitamin D by mouth daily.

DIETARY_SUPPLEMENT

Vitamin D

Patients will receive a multivitamin tablet containing 400-500 IU vitamin D by mouth daily or a combination tablet containing approximately 500 mg elemental calcium and 400-500 IU vitamin D by mouth daily.

Trial Locations (241)

10021

New York Weill Cornell Cancer Center at Cornell University, New York

11203

Kings County Hospital Center, Brooklyn

SUNY Downstate Medical Center, Brooklyn

13057

CCOP - Hematology-Oncology Associates of Central New York, East Syracuse

13210

SUNY Upstate Medical University Hospital, Syracuse

Veterans Affairs Medical Center - Syracuse, Syracuse

14215

Veterans Affairs Medical Center - Buffalo, Buffalo

17701

Susquehanna Cancer Center at Divine Providence Hospital, Williamsport

18501

Mercy Hospital Cancer Center - Scranton, Scranton

20002

Kaiser Permanente at Capitol Hill Medical Center, Washington D.C.

20007

Lombardi Comprehensive Cancer Center at Georgetown University Medical Center, Washington D.C.

20774

Kaiser Permanente Mid-Atlantic Medical Group-Largo Medical Facility, Largo

20850

Kaiser Permanente Capital Area Medical Group - Shady Grove Facility, Rockville

21201

Greenebaum Cancer Center at University of Maryland Medical Center, Baltimore

Veterans Affairs Medical Center - Baltimore, Baltimore

21218

Union Memorial Hospital, Baltimore

21239

Good Samaritan Hospital of Maryland, Baltimore

21244

Kaiser Permanente at Woodlawn Medical Center, Baltimore

21601

Shore Regional Cancer Center at Memorial Hospital - Easton, Easton

21740

John R. Marsh Cancer Center at Washington County Hospital, Hagerstown

22033

Kaiser Permanente Medical Center - Fair Oaks, Fairfax

22401

Fredericksburg Oncology, Incorporated, Fredericksburg

24501

Lynchburg Hematology-Oncology Clinic, Lynchburg

27565

Granville Medical Center, Oxford

27573

Person Memorial Hospital, Roxboro

27609

Duke Health Raleigh Hospital, Raleigh

27710

Duke Cancer Institute, Durham

28359

Southeastern Regional Medical Center, Lumberton

28501

Kinston Medical Specialists, Kinston

29605

Greenville Hospital Cancer Center, Greenville

29615

CCOP - Greenville, Greenville

29646

Self Regional Cancer Center at Self Regional Medical Center, Greenwood

31405

Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler, Savannah

34748

Leesburg Regional Medical Center, Leesburg

36608

Providence Cancer Center at Providence Hospital, Mobile

43402

Wood County Oncology Center, Bowling Green

43560

Flower Hospital Cancer Center, Sylvania

43567

Fulton County Health Center, Wauseon

43606

Toledo Hospital, Toledo

43608

St. Vincent Mercy Medical Center, Toledo

43614

Medical University of Ohio Cancer Center, Toledo

43616

St. Charles Mercy Hospital, Oregon

Toledo Clinic - Oregon, Oregon

43617

CCOP - Toledo Community Hospital, Toledo

43623

St. Anne Mercy Hospital, Toledo

Toledo Clinic, Incorporated - Main Clinic, Toledo

44109

MetroHealth Cancer Care Center at MetroHealth Medical Center, Cleveland

44857

Fisher-Titus Medical Center, Norwalk

44870

North Coast Cancer Care, Incorporated, Sandusky

44883

Mercy Hospital of Tiffin, Tiffin

45801

St. Rita's Medical Center, Lima

45804

Lima Memorial Hospital, Lima

46202

William N. Wishard Memorial Hospital, Indianapolis

46350

Center for Cancer Therapy at LaPorte Hospital and Health Services, La Porte

46360

Saint Anthony Memorial Health Centers, Michigan City

46391

Michiana Hematology Oncology PC - La Porte, Westville

46514

Michiana Hematology-Oncology, PC - Elkhart, Elkhart

46515

Elkhart General Hospital, Elkhart

46563

Michiana Hematology Oncology PC - Plymouth, Plymouth

46601

CCOP - Northern Indiana CR Consortium, South Bend

Memorial Hospital of South Bend, South Bend

46904

Howard Community Hospital, Kokomo

48162

Community Cancer Center of Monroe, Monroe

Mercy Memorial Hospital - Monroe, Monroe

48202

Josephine Ford Cancer Center at Henry Ford Hospital, Detroit

49001

Borgess Medical Center, Kalamazoo

49007

Bronson Methodist Hospital, Kalamazoo

49085

Lakeland Regional Cancer Care Center - St. Joseph, Saint Joseph

Lakeside Cancer Specialists, PLLC, Saint Joseph

49120

Michiana Hematology Oncology PC - Niles, Niles

49221

Hickman Cancer Center at Bixby Medical Center, Adrian

49431

Green Bay Oncology, Limited - Escanaba, Escanaba

49801

Dickinson County Healthcare System, Iron Mountain

50702

Covenant Cancer Treatment Center, Waterloo

51503

Heartland Oncology and Hematology, Council Bluffs

52246

Veterans Affairs Medical Center - Iowa City, Iowa City

53081

St. Nicholas Hospital, Sheboygan

53210

Wheaton Franciscan Cancer Care - St. Joseph, Milwaukee

54143

Bay Area Cancer Care Center at Bay Area Medical Center, Marinette

54154

Green Bay Oncology, Limited - Oconto Falls, Oconto Falls

54235

Green Bay Oncology, Limited - Sturgeon Bay, Sturgeon Bay

54303

Green Bay Oncology, Limited at St. Mary's Hospital, Green Bay

St. Mary's Hospital Medical Center - Green Bay, Green Bay

54401

University of Wisconcin Cancer Center at Aspirus Wausau Hospital, Wausau

54409

Langlade Memorial Hospital, Antigo

54494

Riverview UW Cancer Center at Riverview Hospital, Wisconsin Rapids

55082

Lakeview Hospital, Stillwater

55101

Regions Hospital Cancer Care Center, Saint Paul

55102

United Hospital, Saint Paul

55109

HealthEast Cancer Care at St. John's Hospital, Maplewood

Minnesota Oncology Hematology, PA - Maplewood, Maplewood

55125

Minnesota Oncology Hematology, PA - Woodbury, Woodbury

55337

Fairview Ridges Hospital, Burnsville

55350

Hutchinson Area Health Care, Hutchinson

55387

Ridgeview Medical Center, Waconia

55407

Virginia Piper Cancer Institute at Abbott - Northwestern Hospital, Minneapolis

55415

Hennepin County Medical Center - Minneapolis, Minneapolis

55416

CCOP - Metro-Minnesota, Saint Louis Park

Park Nicollet Cancer Center, Saint Louis Park

55432

Mercy and Unity Cancer Center at Unity Hospital, Fridley

55433

Mercy and Unity Cancer Center at Mercy Hospital, Coon Rapids

55435

Fairview Southdale Hospital, Edina

55805

CCOP - Duluth, Duluth

Miller - Dwan Medical Center, Duluth

56201

Willmar Cancer Center at Rice Memorial Hospital, Willmar

59101

CCOP - Montana Cancer Consortium, Billings

St. Vincent Healthcare Cancer Care Services, Billings

59102

Hematology-Oncology Centers of the Northern Rockies - Billings, Billings

59405

Great Falls Clinic - Main Facility, Great Falls

Sletten Cancer Institute at Benefis Healthcare, Great Falls

59601

St. Peter's Hospital, Helena

59701

St. James Healthcare Cancer Care, Butte

59715

Bozeman Deaconess Cancer Center, Bozeman

59807

Montana Cancer Center at St. Patrick Hospital and Health Sciences Center, Missoula

59901

Glacier Oncology, PLLC, Kalispell

Kalispell Medical Oncology at KRMC, Kalispell

Kalispell Regional Medical Center, Kalispell

60126

Elmhurst Memorial Hospital, Elmhurst

60141

Veterans Affairs Medical Center - Hines, Hines

60153

Cardinal Bernardin Cancer Center at Loyola University Medical Center, Maywood

60504

Rush-Copley Cancer Care Center, Aurora

60525

La Grange Memorial Hospital, La Grange

60612

Veterans Affairs Medical Center - Chicago Westside Hospital, Chicago

60640

Louis A. Weiss Memorial Hospital, Chicago

60901

Provena St. Mary's Regional Cancer Center - Kankakee, Kankakee

61801

Carle Cancer Center at Carle Foundation Hospital, Urbana

CCOP - Carle Cancer Center, Urbana

63110

Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis, St Louis

66606

Cotton-O'Neil Cancer Center, Topeka

68106

CCOP - Missouri Valley Cancer Consortium, Omaha

68114

Methodist Estabrook Cancer Center, Omaha

68122

Immanuel Medical Center, Omaha

68124

Alegant Health Cancer Center at Bergan Mercy Medical Center, Omaha

68130

Lakeside Hospital, Omaha

68510

Cancer Resource Center - Lincoln, Lincoln

68803

Saint Francis Cancer Treatment Center at Saint Francis Memorial Health Center, Grand Island

69103

Callahan Cancer Center at Great Plains Regional Medical Center, North Platte

70112

MBCCOP - LSU Health Sciences Center, New Orleans

Medical Center of Louisiana - New Orleans, New Orleans

70809

Mary Bird Perkins Cancer Center - Baton Rouge, Baton Rouge

71105

Highland Clinic, Shreveport

71210

Louisiana State University Health Sciences Center - Monroe, Monroe

72205

Arkansas Cancer Research Center at University of Arkansas for Medical Sciences, Little Rock

72903

Hembree Mercy Cancer Center at St. Edward Mercy Medical Center, Fort Smith

73104

Oklahoma University Cancer Institute, Oklahoma City

77030

Baylor University Medical Center - Houston, Houston

Ben Taub General Hospital, Houston

St. Luke's Texas Cancer Institute at St. Luke's Episcopal Hospital, Houston

Veterans Affairs Medical Center - Houston, Houston

82801

Welch Cancer Center at Sheridan Memorial Hospital, Sheridan

84003

American Fork Hospital, American Fork

84106

Utah Cancer Specialists at UCS Cancer Center, Salt Lake City

84112

Huntsman Cancer Institute at University of Utah, Salt Lake City

84143

LDS Hospital, Salt Lake City

84157

Jon and Karen Huntsman Cancer Center at Intermountain Medical Center, Murray

84321

Logan Regional Hospital, Logan

84403

Val and Ann Browning Cancer Center at McKay-Dee Hospital Center, Ogden

84604

Utah Valley Regional Medical Center - Provo, Provo

84720

Sandra L. Maxwell Cancer Center, Cedar City

84770

Dixie Regional Medical Center - East Campus, St. George

87102

Lovelace Medical Center - Downtown, Albuquerque

89102

University Medical Center of Southern Nevada, Las Vegas

89106

CCOP - Nevada Cancer Research Foundation, Las Vegas

89135

Nevada Cancer Institute, Las Vegas

90602

Ruby L. Golleher Cancer Program at Presbyterian Intercommunity Hospital, Whittier

91767

Robert and Beverly Lewis Family Cancer Care Center at Pomona Valley Hospital Medical Center, Pomona

92357

Veterans Affairs Medical Center - Loma Linda (Pettis), Loma Linda

93449

Pismo Beach

93901

Salinas Valley Memorial Hospital, Salinas

94115

UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco

94574

Saint Helena Hospital, St. Helena

96701

Kapiolani Medical Center at Pali Momi, ‘Aiea

96793

Pacific Cancer Institute - Maui, Wailuku

96813

Cancer Research Center of Hawaii, Honolulu

OnCare Hawaii, Incorporated - Lusitana, Honolulu

Queen's Cancer Institute at Queen's Medical Center, Honolulu

Straub Clinic and Hospital, Incorporated, Honolulu

96817

Hawaii Medical Center - East, Honolulu

OnCare Hawaii, Incorporated - Kuakini, Honolulu

96826

Kapiolani Medical Center for Women and Children, Honolulu

97227

Kaiser Permanente Health Care - Portland, Portland

97420

Bay Area Hospital, Coos Bay

98104

Minor and James Medical, PLLC, Seattle

98112

Group Health Central Hospital, Seattle

98166

Highline Medical Center Cancer Center, Burien

98195

University Cancer Center at University of Washington Medical Center, Seattle

98221

Island Hospital Cancer Care Center at Island Hospital, Anacortes

98225

St. Joseph Cancer Center, Bellingham

98274

Skagit Valley Hospital Cancer Care Center, Mount Vernon

98284

North Puget Oncology at United General Hospital, Sedro-Woolley

98310

Olympic Hematology and Oncology, Bremerton

99202

Cancer Care Northwest - Spokane South, Spokane

99218

Evergreen Hematology and Oncology, PS, Spokane

99336

Columbia Basin Hematology, Kennewick

06520-8028

Yale Cancer Center, New Haven

06516

Veterans Affairs Medical Center - West Haven, West Haven

60612-7243

University of Illinois Cancer Center, Chicago

60637-1470

University of Chicago Cancer Research Center, Chicago

46514-2098

Elkhart Clinic, LLC, Elkhart

46202-5289

Indiana University Melvin and Bren Simon Cancer Center, Indianapolis

46545-1470

Michiana Hematology-Oncology, PC - South Bend, Mishawaka

Saint Joseph Regional Medical Center, Mishawaka

52242-1002

Holden Comprehensive Cancer Center at University of Iowa, Iowa City

71130-3932

Feist-Weiller Cancer Center at Louisiana State University Health Sciences, Shreveport

02114

Massachusetts General Hospital, Boston

02115

Dana-Farber/Brigham and Women's Cancer Center, Boston

Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute, Boston

01854

Lowell General Hospital, Lowell

01757

Dana-Farber/Brigham and Women's Cancer Center at Milford Regional Medical Center, Milford

49007-3731

West Michigan Cancer Center, Kalamazoo

55805-1983

Duluth Clinic Cancer Center - Duluth, Duluth

55422-2900

Humphrey Cancer Center at North Memorial Outpatient Center, Robbinsdale

59107-7000

Billings Clinic - Downtown, Billings

59405-5309

Big Sky Oncology, Great Falls

59807-7877

Montana Cancer Specialists at Montana Cancer Center, Missoula

68848-1990

Good Samaritan Cancer Center at Good Samaritan Hospital, Kearney

68131-2197

Creighton University Medical Center, Omaha

68198-6805

UNMC Eppley Cancer Center at the University of Nebraska Medical Center, Omaha

03301

New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care, Concord

03833

Center for Cancer Care at Exeter Hospital, Exeter

03106

New Hampshire Oncology - Hematology, PA - Hooksett, Hooksett

03053

Dana-Farber Cancer Institute at Londonderry, Londonderry

03103

Elliot Regional Cancer Center at Elliot Hospital, Manchester

07018-1095

Veterans Affairs Medical Center - East Orange, East Orange

08360

Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare, Vineland

87131-5636

University of New Mexico Cancer Center, Albuquerque

14263-0001

Roswell Park Cancer Institute, Buffalo

43210-1240

Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center, Columbus

43537-1839

Northwest Ohio Oncology Center, Maumee

37208-3599

MBCCOP - Meharry Medical College - Nashville, Nashville

05602

Mountainview Medical, Berlin Corners

05401

Fletcher Allen Health Care - University Health Center Campus, Burlington

98122-4307

Swedish Cancer Institute at Swedish Medical Center - First Hill Campus, Seattle

99204-2967

Rockwood Clinic Cancer Treatment Center, Spokane

98801-2028

Wenatchee Valley Medical Center, Wenatchee

54301-3526

Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center, Green Bay

54307-3508

St. Vincent Hospital Regional Cancer Center, Green Bay

54221-1450

Holy Family Memorial Medical Center Cancer Care Center, Manitowoc

T6G 1Z2

Cross Cancer Institute at University of Alberta, Edmonton

V5Z 3P1

University of British Columbia, Vancouver

N6A 4L6

London Regional Cancer Program at London Health Sciences Centre, London

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

collaborator

SWOG Cancer Research Network

NETWORK

collaborator

Eastern Cooperative Oncology Group

NETWORK

collaborator

NCIC Clinical Trials Group

NETWORK

collaborator

Novartis Pharmaceuticals

INDUSTRY

lead

Alliance for Clinical Trials in Oncology

OTHER