Zoledronate in Preventing Osteoporosis and Bone Fractures in Patients With Locally Advanced Nonmetastatic Prostate Cancer Undergoing Radiation Therapy and Hormone Therapy

PHASE3CompletedINTERVENTIONAL
Enrollment

109

Participants

Timeline

Start Date

March 31, 2006

Primary Completion Date

November 30, 2014

Study Completion Date

November 30, 2014

Conditions
OsteoporosisProstate Cancer
Interventions
DIETARY_SUPPLEMENT

Calcium

A single dose of 500 mg of elemental calcium orally each day for 3 years.

DIETARY_SUPPLEMENT

Zoledronic acid

Patients receive IV over 15 minutes once every 6 months for 3 years. The goal dose of zoledronic acid is 4 mg, but the selection of dose is determined based on calculated creatinine clearance at baseline.

RADIATION

radiation therapy

Patients must receive external beam irradiation, brachytherapy (HDR or LDR), or a combination of external beam irradiation and brachytherapy at the discretion of the treating physician. Dose/duration also will be at the discretion of the treating physician; however, dose will not exceed 45 Gy to 100% of the proximal femur, and no proximal femur will receive ≥ 60 Gy.

DRUG

LHRH

LHRH therapy must take place for a minimum of one year. Choice of LHRH agonist, dose, and duration are at the discretion of the treating physician.

DIETARY_SUPPLEMENT

Vitamin D

400 IU (10μg), orally each day for 3 years.

Trial Locations (88)

11209

Veterans Affairs Medical Center - Brooklyn, Brooklyn

13057

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

13905

Lourdes Regional Cancer Center, Binghamton

17325

Adams Cancer Center, Gettysburg

17405

York Cancer Center at Apple Hill Medical Center, York

19001

Rosenfeld Cancer Center at Abington Memorial Hospital, Abington

19010

Bryn Mawr Hospital, Bryn Mawr

19096

Lankenau Cancer Center at Lankenau Hospital, Wynnewood

21229

St. Agnes Hospital Cancer Center, Baltimore

23507

Sentara Cancer Institute at Sentara Norfolk General Hospital, Norfolk

27534

Wayne Radiation Oncology, Goldsboro

27607

Cancer Centers of North Carolina - Raleigh, Raleigh

27893

Wilmed Radiation Oncology Services, Wilson

28801

Mission Hospitals - Memorial Campus, Asheville

30501

Northeast Georgia Medical Center, Gainesville

37662

Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center, Kingsport

44307

McDowell Cancer Center at Akron General Medical Center, Akron

44460

Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford, Salem

44691

Cancer Treatment Center, Wooster

45069

Precision Radiotherapy at University Pointe, West Chester

45267

Charles M. Barrett Cancer Center at University Hospital, Cincinnati

46202

Methodist Cancer Center at Methodist Hospital, Indianapolis

46526

Center for Cancer Care at Goshen General Hospital, Goshen

48202

Josephine Ford Cancer Center at Henry Ford Hospital, Detroit

53051

Community Memorial Hospital Cancer Care Center, Menomonee Falls

53215

Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center, Milwaukee

53226

Medical College of Wisconsin Cancer Center, Milwaukee

53227

West Allis Memorial Hospital, West Allis

53295

Veterans Affairs Medical Center - Milwaukee, Milwaukee

54143

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

54911

Theda Care Cancer Institute, Appleton

56303

CentraCare Clinic - River Campus, Saint Cloud

Coborn Cancer Center, Saint Cloud

59101

CCOP - Montana Cancer Consortium, Billings

Northern Rockies Radiation Oncology Center, Billings

59405

Great Falls Clinic - Main Facility, Great Falls

60005

Northwest Community Hospital, Arlington Heights

60426

Ingalls Cancer Care Center at Ingalls Memorial Hospital, Harvey

60461

Saint James Hospital and Health Centers Comprehensive Cancer Institute - Olympia Fields, Olympia Fields

61801

CCOP - Carle Cancer Center, Urbana

62002

Saint Anthony's Hospital at Saint Anthony's Health Center, Alton

63110

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

63141

CCOP - St. Louis-Cape Girardeau, St Louis

David C. Pratt Cancer Center at St. John's Mercy, St Louis

63701

Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital, Cape Girardeau

64131

CCOP - Kansas City, Kansas City

65804

St. John's Regional Health Center, Springfield

65807

Hulston Cancer Center at Cox Medical Center South, Springfield

80933

Penrose Cancer Center at Penrose Hospital, Colorado Springs

81004

St. Mary - Corwin Regional Medical Center, Pueblo

84143

LDS Hospital, Salt Lake City

84157

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

84403

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

84604

Utah Valley Regional Medical Center - Provo, Provo

84770

Dixie Regional Medical Center - East Campus, St. George

89102

University Medical Center of Southern Nevada, Las Vegas

89106

CCOP - Nevada Cancer Research Foundation, Las Vegas

89502

Renown Institute for Cancer at Renown Regional Medical Center, Reno

91767

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

95661

Radiation Oncology Center - Roseville, Roseville

95815

Radiological Associates of Sacramento Medical Group, Incorporated, Sacramento

95926

Enloe Cancer Center at Enloe Medical Center, Chico

98902

North Star Lodge Cancer Center at Yakima Valley Memorial Hospital, Yakima

90089-9181

USC/Norris Comprehensive Cancer Center and Hospital, Los Angeles

40536-0093

Lucille P. Markey Cancer Center at University of Kentucky, Lexington

21231-2410

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore

48201-1379

Barbara Ann Karmanos Cancer Institute, Detroit

49007-3731

West Michigan Cancer Center, Kalamazoo

03431

Kingsbury Center for Cancer Care at Cheshire Medical Center, Keene

03756-0002

Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center, Lebanon

08103

Cancer Institute of New Jersey at Cooper University Hospital - Camden, Camden

08360

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

08043

Cancer Institute of New Jersey at Cooper - Voorhees, Voorhees Township

14263-0001

Roswell Park Cancer Institute, Buffalo

44309-2090

Summa Center for Cancer Care at Akron City Hospital, Akron

19301-1792

Cancer Center of Paoli Memorial Hospital, Paoli

19111-2497

Fox Chase Cancer Center - Philadelphia, Philadelphia

05819

Norris Cotton Cancer Center - North, Saint Johnsbury

23708-2197

Naval Medical Center - Portsmouth, Portsmouth

54307-3508

St. Vincent Hospital Regional Cancer Center, Green Bay

V8R 6V5

British Columbia Cancer Agency - Vancouver Island Centre, Victoria

A1B 3V6

Doctor H. Bliss Murphy Cancer Centre, St. John's

L8V 5C2

Margaret and Charles Juravinski Cancer Centre, Hamilton

P7B 6V4

Cancer Care Program at Thunder Bay Regional Health Sciences, Thunder Bay

H1T 2M4

Maisonneuve-Rosemont Hospital, Montreal

G1R 2J6

Centre Hospitalier Universitaire de Quebec, Québec

J1H 5N4

CHUS-Hopital Fleurimont, Sherbrooke

S4T 7T1

Allan Blair Cancer Centre at Pasqua Hospital, Regina

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

Radiation Therapy Oncology Group

NETWORK

NCT00329797 - Zoledronate in Preventing Osteoporosis and Bone Fractures in Patients With Locally Advanced Nonmetastatic Prostate Cancer Undergoing Radiation Therapy and Hormone Therapy | Biotech Hunter | Biotech Hunter