S0702: Osteonecrosis of the Jaw in Patients With Cancer Receiving Zoledronic Acid for Bone Metastases

July 3, 2019 updated by: Southwest Oncology Group

S0702: A Prospective Observational Multicenter Cohort Study to Assess the Incidence of Osteonecrosis of the Jaw (ONJ) in Cancer Patients With Bone Metastases Starting Zoledronic Acid Treatment

RATIONALE: Gathering information about how often osteonecrosis of the jaw occurs in patients receiving zoledronic acid for bone metastases may help doctors learn more about the disease and provide the best follow-up care.

PURPOSE: This clinical trial is studying osteonecrosis of the jaw in patients with cancer who are receiving zoledronic acid for bone metastases.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Procedure: assessment of therapy complications

Detailed Description

OBJECTIVES:

Primary

To prospectively access the cumulative incidence of osteonecrosis of the jaw (ONJ) at 3 years in cancer patients with bone metastasis receiving zoledronic acid treatment.

Secondary

To describe the clinical presentation and natural history of ONJ.
To identify potential risk factors for the development of ONJ.
To estimate the cumulative incidence of ONJ at 3 years for different tumor types (i.e., breast cancer, multiple myeloma, prostate cancer, lung cancer, and other cancers).
To better define the patient-related outcomes of ONJ.

OUTLINE: This is a multicenter study.

Patients undergo dental assessments at baseline and every 3-6 months for 3 years.

Study Type

Observational

Enrollment (Actual)

3571

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Mexico
- - Tlalpan, Mexico, 14080
    - Instituto Nacional de Cancerologia
Saudi Arabia
- - Riyadh, Saudi Arabia, 11211
    - King Faisal Specialist Hospital and Research Center
United States
- Alabama
  - Anniston, Alabama, United States, 36207
    - Regional Medical Center
  - Mobile, Alabama, United States, 36608
    - Providence Cancer Center at Providence Hospital
- Alaska
  - Anchorage, Alaska, United States, 99508
    - Providence Cancer Center
  - Fairbanks, Alaska, United States, 99701
    - Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital
- Arkansas
  - Jonesboro, Arkansas, United States, 72401
    - NEA Medical Clinic - East Matthews
  - Little Rock, Arkansas, United States, 72205
    - Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
- California
  - Castro Valley, California, United States, 94546
    - East Bay Radiation Oncology Center
  - Castro Valley, California, United States, 94546
    - Valley Medical Oncology Consultants - Castro Valley
  - Concord, California, United States, 94524-4110
    - Cancer Care Center at John Muir Health - Concord Campus
  - Duarte, California, United States, 91010-3000
    - City of Hope Comprehensive Cancer Center
  - Fairfield, California, United States, 94533
    - North Bay Cancer Center
  - Fremont, California, United States, 94538
    - Valley Medical Oncology
  - Grass Valley, California, United States, 95945
    - Sierra Nevada Cancer Center at Sierra Nevada Memorial Hospital
  - Long Beach, California, United States, 90806
    - Breastlink Medical Group, Incorporated at Long Beach Memorial Medical Center
  - Los Angeles, California, United States, 90089-9181
    - USC/Norris Comprehensive Cancer Center and Hospital
  - Martinez, California, United States, 94553-3156
    - Contra Costa Regional Medical Center
  - Marysville, California, United States, 95901
    - Tibotec Therapeutics - Division of Ortho Biotech Products, LP
  - Merced, California, United States, 95340
    - Mercy Cancer Center at Mercy Medical Center
  - Mountain View, California, United States, 94040
    - El Camino Hospital Cancer Center
  - Oakland, California, United States, 94609
    - Alta Bates Summit Medical Center - Summit Campus
  - Oakland, California, United States, 94602
    - Highland General Hospital
  - Oakland, California, United States, 94609
    - Larry G Strieff MD Medical Corporation
  - Oakland, California, United States, 94609
    - CCOP - Bay Area Tumor Institute
  - Oakland, California, United States, 94609
    - Bay Area Breast Surgeons, Incorporated
  - Oakland, California, United States, 94609
    - Tom K Lee, Incorporated
  - Oakland, California, United States, 94612
    - Epic Care - Oakland
  - Orange, California, United States, 92868
    - St. Joseph Hospital Regional Cancer Center - Orange
  - Pleasanton, California, United States, 94588
    - Valley Medical Oncology Consultants - Pleasanton
  - Sacramento, California, United States, 95817
    - University of California Davis Cancer Center
  - San Pablo, California, United States, 94806
    - Doctors Medical Center - San Pablo Campus
  - Truckee, California, United States, 96161
    - Tahoe Forest Cancer Center
  - Walnut Creek, California, United States, 94598
    - John Muir/Mt. Diablo Comprehensive Cancer Center
- Colorado
  - Aurora, Colorado, United States, 80012
    - Aurora Presbyterian Hospital
  - Boulder, Colorado, United States, 80301-9019
    - Boulder Community Hospital
  - Colorado Springs, Colorado, United States, 80933
    - Penrose Cancer Center at Penrose Hospital
  - Colorado Springs, Colorado, United States, 80909
    - Memorial Hospital Cancer Center - Colorado Springs
  - Denver, Colorado, United States, 80210
    - Porter Adventist Hospital
  - Denver, Colorado, United States, 80220
    - Rose Medical Center
  - Denver, Colorado, United States, 80218
    - Presbyterian - St. Luke's Medical Center
  - Denver, Colorado, United States, 80204
    - St. Anthony Central Hospital
  - Denver, Colorado, United States, 80218
    - St. Joseph Hospital
  - Denver, Colorado, United States, 80222
    - CCOP - Colorado Cancer Research Program
  - Englewood, Colorado, United States, 80110
    - Swedish Medical Center
  - Fort Collins, Colorado, United States, 80524
    - Poudre Valley Hospital
  - Fort Collins, Colorado, United States, 80528
    - Front Range Cancer Specialists
  - Grand Junction, Colorado, United States, 81502
    - St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
  - Greeley, Colorado, United States, 80631
    - North Colorado Medical Center
  - Littleton, Colorado, United States, 80122
    - Littleton Adventist Hospital
  - Lone Tree, Colorado, United States, 80124
    - Sky Ridge Medical Center
  - Longmont, Colorado, United States, 80501
    - Hope Cancer Care Center at Longmont United Hospital
  - Loveland, Colorado, United States, 80539
    - McKee Medical Center
  - Parker, Colorado, United States, 80138
    - Parker Adventist Hospital
  - Pueblo, Colorado, United States, 81004
    - St. Mary - Corwin Regional Medical Center
  - Thornton, Colorado, United States, 80229
    - North Suburban Medical Center
  - Wheat Ridge, Colorado, United States, 80033
    - Exempla Lutheran Medical Center
- Connecticut
  - Hartford, Connecticut, United States, 06105
    - Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
- Delaware
  - Lewes, Delaware, United States, 19958
    - Tunnell Cancer Center at Beebe Medical Center
  - Newark, Delaware, United States, 19713
    - CCOP - Christiana Care Health Services
- Florida
  - Fort Lauderdale, Florida, United States, 33316
    - Broward General Medical Center Cancer Center
  - Pensacola, Florida, United States, 32504
    - Sacred Heart Cancer Center at Sacred Heart Hospital
  - Pensacola, Florida, United States, 32514
    - Sacred Heart Medical Oncology
  - Tampa, Florida, United States, 33612-9497
    - H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
  - Titusville, Florida, United States, 32796
    - Space Coast Medical Associates
- Georgia
  - Atlanta, Georgia, United States, 30309
    - Piedmont Hospital
  - Atlanta, Georgia, United States, 30342-1611
    - Northside Hospital Cancer Center
  - Atlanta, Georgia, United States, 30342-1701
    - Saint Joseph's Hospital of Atlanta
  - Atlanta, Georgia, United States, 30342
    - CCOP - Atlanta Regional
  - Austell, Georgia, United States, 30106
    - WellStar Cobb Hospital
  - Columbus, Georgia, United States, 31904
    - John B. Amos Cancer Center
  - Decatur, Georgia, United States, 30033
    - Charles B. Eberhart Cancer Center at DeKalb Medical Center
  - Fayetteville, Georgia, United States, 30214
    - Piedmont Fayette Hospital
  - Gainesville, Georgia, United States, 30501
    - Northeast Georgia Medical Center
  - Lawrenceville, Georgia, United States, 30045
    - Gwinnett Medical Center
  - Marietta, Georgia, United States, 30060
    - Kennestone Cancer Center at Wellstar Kennestone Hospital
  - Riverdale, Georgia, United States, 30274-2600
    - Southern Regional Medical Center
  - Rome, Georgia, United States, 30165
    - Harbin Clinic Cancer Center - Medical Oncology
  - Savannah, Georgia, United States, 31403-3089
    - Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
  - Valdosta, Georgia, United States, 31602
    - Pearlman Comprehensive Cancer Center at South Georgia Medical Center
- Hawaii
  - 'Aiea, Hawaii, United States, 96701
    - Kapiolani Medical Center at Pali Momi
  - Honolulu, Hawaii, United States, 96813
    - Cancer Research Center of Hawaii
  - Honolulu, Hawaii, United States, 96826
    - Kapiolani Medical Center for Women and Children
  - Honolulu, Hawaii, United States, 96813
    - OnCare Hawaii, Incorporated - Lusitana
  - Honolulu, Hawaii, United States, 96813
    - Queen's Cancer Institute at Queen's Medical Center
  - Honolulu, Hawaii, United States, 96813
    - Straub Clinic and Hospital, Incorporated
  - Honolulu, Hawaii, United States, 96817
    - Hawaii Medical Center - East
  - Honolulu, Hawaii, United States, 96817
    - OnCare Hawaii, Incorporated - Kuakini
  - Honolulu, Hawaii, United States, 96859
    - Tripler Army Medical Center
  - Lihue, Hawaii, United States, 96766
    - Kauai Medical Clinic
  - Wailuku, Hawaii, United States, 96793
    - Maui Memorial Medical Center
  - Wailuku, Hawaii, United States, 96793
    - Pacific Cancer Institute - Maui
- Idaho
  - Boise, Idaho, United States, 83712
    - Mountain States Tumor Institute at St. Luke's Regional Medical Center
  - Boise, Idaho, United States, 83706
    - Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
  - Fruitland, Idaho, United States, 83619
    - Saint Luke's Mountain States Tumor Institute - Fruitland
  - Lewiston, Idaho, United States, 83501
    - St. Joseph Regional Medical Center
  - Meridian, Idaho, United States, 83642
    - Mountain States Tumor Institute - Meridian
  - Nampa, Idaho, United States, 83686
    - Saint Luke's Mountain States Tumor Institute
  - Twin Falls, Idaho, United States, 83301
    - Mountain States Tumor Institute at St. Luke's
- Illinois
  - Aurora, Illinois, United States, 60504
    - Rush-Copley Cancer Care Center
  - Carbondale, Illinois, United States, 62902
    - Memorial Hospital of Carbondale
  - Chicago, Illinois, United States, 60640
    - Louis A. Weiss Memorial Hospital
  - Chicago, Illinois, United States, 60612-3785
    - John H. Stroger, Jr. Hospital of Cook County
  - Decatur, Illinois, United States, 62526
    - Decatur Memorial Hospital Cancer Care Institute
  - Elgin, Illinois, United States, 60123
    - Sherman Hospital
  - Evanston, Illinois, United States, 60201-1781
    - Evanston Hospital
  - Geneva, Illinois, United States, 60134
    - Delnor Hospital - Geneva
  - Hines, Illinois, United States, 60141
    - Veterans Affairs Medical Center - Hines
  - Maywood, Illinois, United States, 60153
    - Cardinal Bernardin Cancer Center at Loyola University Medical Center
  - Moline, Illinois, United States, 61265
  - Moline, Illinois, United States, 61265
    - Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
  - Mount Vernon, Illinois, United States, 62864
    - Good Samaritan Regional Health Center
  - River Forest, Illinois, United States, 60305
    - West Suburban Center for Cancer Care
  - Springfield, Illinois, United States, 62781-0001
    - Regional Cancer Center at Memorial Medical Center
  - Urbana, Illinois, United States, 61801
    - CCOP - Carle Cancer Center
  - Warrenville, Illinois, United States, 60555
    - Central Dupage Cancer Center
- Indiana
  - Beech Grove, Indiana, United States, 46107
    - St. Francis Hospital and Health Centers - Beech Grove Campus
  - Elkhart, Indiana, United States, 46515
    - Elkhart General Hospital
  - Elkhart, Indiana, United States, 46514-2098
    - Elkhart Clinic, LLC
  - Elkhart, Indiana, United States, 46514
    - Michiana Hematology-Oncology, PC - Elkhart
  - Kokomo, Indiana, United States, 46904
    - Howard Community Hospital
  - La Porte, Indiana, United States, 46350
    - Center for Cancer Therapy at LaPorte Hospital and Health Services
  - Michigan City, Indiana, United States, 46360
    - Saint Anthony Memorial Health Centers
  - Mishawaka, Indiana, United States, 46545-1470
    - Michiana Hematology-Oncology, PC - South Bend
  - Mishawaka, Indiana, United States, 46545-1470
    - Saint Joseph Regional Medical Center
  - Plymouth, Indiana, United States, 46563
    - Michiana Hematology Oncology PC - Plymouth
  - Richmond, Indiana, United States, 47374
    - Reid Hospital & Health Care Services
  - South Bend, Indiana, United States, 46601
    - Memorial Hospital of South Bend
  - South Bend, Indiana, United States, 46601
    - CCOP - Northern Indiana CR Consortium
  - Westville, Indiana, United States, 46391
    - Michiana Hematology Oncology PC - La Porte
- Iowa
  - Ames, Iowa, United States, 50010
    - McFarland Clinic, PC
  - Bettendorf, Iowa, United States, 52722
  - Cedar Rapids, Iowa, United States, 52403
    - Cedar Rapids Oncology Associates
  - Cedar Rapids, Iowa, United States, 52403
    - Mercy Regional Cancer Center at Mercy Medical Center
  - Clive, Iowa, United States, 50325
    - Medical Oncology and Hematology Associates - West Des Moines
  - Davenport, Iowa, United States, 52803
    - Genesis Regional Cancer Center at Genesis Medical Center
  - Des Moines, Iowa, United States, 50309
    - CCOP - Iowa Oncology Research Association
  - Des Moines, Iowa, United States, 50309
    - John Stoddard Cancer Center at Iowa Methodist Medical Center
  - Des Moines, Iowa, United States, 50309
    - Medical Oncology and Hematology Associates at John Stoddard Cancer Center
  - Des Moines, Iowa, United States, 50314
    - Medical Oncology and Hematology Associates at Mercy Cancer Center
  - Des Moines, Iowa, United States, 50314
    - Mercy Cancer Center at Mercy Medical Center - Des Moines
  - Des Moines, Iowa, United States, 50316
    - John Stoddard Cancer Center at Iowa Lutheran Hospital
  - Mason City, Iowa, United States, 50401
    - Mercy Cancer Center at Mercy Medical Center - North Iowa
  - Sioux City, Iowa, United States, 51101
    - Siouxland Hematology-Oncology Associates, LLP
  - Sioux City, Iowa, United States, 51102
    - Mercy Medical Center - Sioux City
  - Sioux City, Iowa, United States, 51104
    - St. Luke's Regional Medical Center
- Kansas
  - Chanute, Kansas, United States, 66720
    - Cancer Center of Kansas, PA - Chanute
  - Dodge City, Kansas, United States, 67801
    - Cancer Center of Kansas, PA - Dodge City
  - El Dorado, Kansas, United States, 67042
    - Cancer Center of Kansas, PA - El Dorado
  - Fort Scott, Kansas, United States, 66701
    - Cancer Center of Kansas - Fort Scott
  - Independence, Kansas, United States, 67301
    - Cancer Center of Kansas-Independence
  - Kingman, Kansas, United States, 67068
    - Cancer Center of Kansas, PA - Kingman
  - Lawrence, Kansas, United States, 66044
    - Lawrence Memorial Hospital
  - Liberal, Kansas, United States, 67901
    - Cancer Center of Kansas, PA - Liberal
  - McPherson, Kansas, United States, 67460
    - Cancer Center of Kansas, PA - McPherson
  - Newton, Kansas, United States, 67114
    - Cancer Center of Kansas, PA - Newton
  - Overland Park, Kansas, United States, 66209
    - Menorah Medical Center
  - Overland Park, Kansas, United States, 66213
    - Saint Luke's Hospital - South
  - Parsons, Kansas, United States, 67357
    - Cancer Center of Kansas, PA - Parsons
  - Prairie Village, Kansas, United States, 66208
    - CCOP - Kansas City
  - Pratt, Kansas, United States, 67124
    - Cancer Center of Kansas, PA - Pratt
  - Salina, Kansas, United States, 67401
    - Cancer Center of Kansas, PA - Salina
  - Salina, Kansas, United States, 67401
    - Tammy Walker Cancer Center at Salina Regional Health Center
  - Topeka, Kansas, United States, 66606
    - Cotton-O'Neil Cancer Center
  - Wellington, Kansas, United States, 67152
    - Cancer Center of Kansas, PA - Wellington
  - Wichita, Kansas, United States, 67208
    - Cancer Center of Kansas, PA - Medical Arts Tower
  - Wichita, Kansas, United States, 67214
    - Cancer Center of Kansas, PA - Wichita
  - Wichita, Kansas, United States, 67214
    - CCOP - Wichita
  - Wichita, Kansas, United States, 67214
    - Via Christi Cancer Center at Via Christi Regional Medical Center
  - Wichita, Kansas, United States, 67208
    - Associates in Womens Health, PA - North Review
  - Winfield, Kansas, United States, 67156
    - Cancer Center of Kansas, PA - Winfield
- Louisiana
  - Baton Rouge, Louisiana, United States, 70809
    - Ochsner Health Center - Bluebonnet
  - Covington, Louisiana, United States, 70433
    - Ochsner Health Center - Covington
  - Monroe, Louisiana, United States, 71210
    - Louisiana State University Health Sciences Center - Monroe
  - New Orleans, Louisiana, United States, 70121
    - CCOP - Ochsner
  - New Orleans, Louisiana, United States, 70121
    - Ochsner Cancer Institute at Ochsner Clinic Foundation
  - Shreveport, Louisiana, United States, 71105
    - Highland Clinic
  - Shreveport, Louisiana, United States, 71130-3932
    - Feist-Weiller Cancer Center at Louisiana State University Health Sciences
- Maryland
  - Elkton, Maryland, United States, 21921
    - Union Hospital of Cecil County
- Massachusetts
  - Methuen, Massachusetts, United States, 01844
    - Caritas Holy Family Hospital
- Michigan
  - Adrian, Michigan, United States, 49221
    - Hickman Cancer Center at Bixby Medical Center
  - Ann Arbor, Michigan, United States, 48109-0942
    - University of Michigan Comprehensive Cancer Center
  - Ann Arbor, Michigan, United States, 48106-0995
    - Saint Joseph Mercy Cancer Center
  - Ann Arbor, Michigan, United States, 48106
    - CCOP - Michigan Cancer Research Consortium
  - Battle Creek, Michigan, United States, 49017
    - Battle Creek Health System Cancer Care Center
  - Bay City, Michigan, United States, 48708
    - Bay Regional Medical Center
  - Big Rapids, Michigan, United States, 49307
    - Mecosta County Medical Center
  - Dearborn, Michigan, United States, 48123-2500
    - Oakwood Cancer Center at Oakwood Hospital and Medical Center
  - Detroit, Michigan, United States, 48202
    - Josephine Ford Cancer Center at Henry Ford Hospital
  - Escanaba, Michigan, United States, 49431
    - Green Bay Oncology, Limited - Escanaba
  - Flint, Michigan, United States, 48503
    - Hurley Medical Center
  - Flint, Michigan, United States, 48503
    - Genesys Hurley Cancer Institute
  - Flint, Michigan, United States, 48532
    - McLaren Cancer Institute
  - Flint, Michigan, United States, 48532
    - Singh and Arora Hematology Oncology, PC
  - Grand Rapids, Michigan, United States, 49503
    - Butterworth Hospital at Spectrum Health
  - Grand Rapids, Michigan, United States, 49503
    - CCOP - Grand Rapids
  - Grand Rapids, Michigan, United States, 49503
    - Lacks Cancer Center at Saint Mary's Health Care
  - Grosse Pointe Woods, Michigan, United States, 48236
    - Van Elslander Cancer Center at St. John Hospital and Medical Center
  - Iron Mountain, Michigan, United States, 49801
    - Dickinson County Healthcare System
  - Jackson, Michigan, United States, 49201
    - Foote Memorial Hospital
  - Kalamazoo, Michigan, United States, 49007
    - Bronson Methodist Hospital
  - Kalamazoo, Michigan, United States, 49001
    - Borgess Medical Center
  - Kalamazoo, Michigan, United States, 49007-3731
    - West Michigan Cancer Center
  - Lansing, Michigan, United States, 48912-1811
    - Sparrow Regional Cancer Center
  - Lansing, Michigan, United States, 48910
    - Breslin Cancer Center at Ingham Regional Medical Center
  - Lapeer, Michigan, United States, 48446
    - Great Lakes Cancer Institute - Lapeer Campus
  - Livonia, Michigan, United States, 48154
    - St. Mary Mercy Hospital
  - Monroe, Michigan, United States, 48162
    - Community Cancer Center of Monroe
  - Monroe, Michigan, United States, 48162
    - Mercy Memorial Hospital - Monroe
  - Mount Clemens, Michigan, United States, 48043
    - Clemens Regional Medical Center
  - Muskegon, Michigan, United States, 49444
    - Mercy General Health Partners
  - Petoskey, Michigan, United States, 49770
    - Northern Michigan Hospital
  - Pontiac, Michigan, United States, 48341-2985
    - St. Joseph Mercy Oakland
  - Port Huron, Michigan, United States, 48060
    - Mercy Regional Cancer Center at Mercy Hospital
  - Reed City, Michigan, United States, 49677
    - Spectrum Health Reed City Hospital
  - Royal Oak, Michigan, United States, 48073
    - William Beaumont Hospital - Royal Oak Campus
  - Saginaw, Michigan, United States, 48601
    - Seton Cancer Institute at Saint Mary's - Saginaw
  - Saint Joseph, Michigan, United States, 49085
    - Lakeside Cancer Specialists, PLLC
  - Saint Joseph, Michigan, United States, 49085
    - Lakeland Regional Cancer Care Center - St. Joseph
  - Southfield, Michigan, United States, 48075
    - Providence Cancer Institute at Providence Hospital - Southfield Campus
  - Traverse City, Michigan, United States, 49684
    - Munson Medical Center
  - Warren, Michigan, United States, 48093
    - St. John Macomb Hospital
- Minnesota
  - Brainerd, Minnesota, United States, 56401
    - St. Joseph's Medical Center
  - Burnsville, Minnesota, United States, 55337
    - Fairview Ridges Hospital
  - Coon Rapids, Minnesota, United States, 55433
    - Mercy and Unity Cancer Center at Mercy Hospital
  - Duluth, Minnesota, United States, 55805
    - CCOP - Duluth
  - Duluth, Minnesota, United States, 55805-1983
    - Duluth Clinic Cancer Center - Duluth
  - Duluth, Minnesota, United States, 55805
    - Miller - Dwan Medical Center
  - Edina, Minnesota, United States, 55435
    - Fairview Southdale Hospital
  - Fridley, Minnesota, United States, 55432
    - Mercy and Unity Cancer Center at Unity Hospital
  - Hutchinson, Minnesota, United States, 55350
    - Hutchinson Area Health Care
  - Maplewood, Minnesota, United States, 55109
    - HealthEast Cancer Care at St. John's Hospital
  - Maplewood, Minnesota, United States, 55109
    - Minnesota Oncology - Maplewood
  - Minneapolis, Minnesota, United States, 55407
    - Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
  - Minneapolis, Minnesota, United States, 55415
    - Hennepin County Medical Center - Minneapolis
  - New Ulm, Minnesota, United States, 56073
    - New Ulm Medical Center
  - Robbinsdale, Minnesota, United States, 55422-2900
    - Humphrey Cancer Center at North Memorial Outpatient Center
  - Saint Louis Park, Minnesota, United States, 55416
    - CCOP - Metro-Minnesota
  - Saint Louis Park, Minnesota, United States, 55416
    - Park Nicollet Cancer Center
  - Saint Paul, Minnesota, United States, 55102
    - United Hospital
  - Saint Paul, Minnesota, United States, 55101
    - Regions Hospital Cancer Care Center
  - Shakopee, Minnesota, United States, 55379
    - St. Francis Cancer Center at St. Francis Medical Center
  - Stillwater, Minnesota, United States, 55082
    - Lakeview Hospital
  - Waconia, Minnesota, United States, 55387
    - Ridgeview Medical Center
  - Willmar, Minnesota, United States, 56201
    - Willmar Cancer Center at Rice Memorial Hospital
  - Woodbury, Minnesota, United States, 55125
    - Minnesota Oncology - Woodbury
- Mississippi
  - Jackson, Mississippi, United States, 39216
    - University of Mississippi Cancer Clinic
  - Jackson, Mississippi, United States, 39216
    - Veterans Affairs Medical Center - Jackson
  - Pascagoula, Mississippi, United States, 39581
    - Regional Cancer Center at Singing River Hospital
- Missouri
  - Cape Girardeau, Missouri, United States, 63703
    - Saint Francis Medical Center
  - Cape Girardeau, Missouri, United States, 63703
    - Southeast Cancer Center
  - Jefferson City, Missouri, United States, 65109
    - Goldschmidt Cancer Center
  - Kansas City, Missouri, United States, 64128
    - Veterans Affairs Medical Center - Kansas City
  - Kansas City, Missouri, United States, 64116
    - North Kansas City Hospital
  - Kansas City, Missouri, United States, 64132
    - Research Medical Center
  - Kansas City, Missouri, United States, 64111
    - Saint Luke's Cancer Institute at Saint Luke's Hospital
  - Kansas City, Missouri, United States, 64118
    - Heartland Hematology Oncology Associates, Incorporated
  - Lee's Summit, Missouri, United States, 64086
    - Saint Luke's East - Lee's Summit
  - Liberty, Missouri, United States, 64068
    - Parvin Radiation Oncology
  - Saint Joseph, Missouri, United States, 64506
    - Heartland Regional Medical Center
  - Saint Joseph, Missouri, United States, 64507
    - Saint Joseph Oncology, Incorporated
  - Saint Louis, Missouri, United States, 63131
    - Missouri Baptist Cancer Center
  - Saint Louis, Missouri, United States, 63141
    - CCOP - St. Louis-Cape Girardeau
  - Saint Louis, Missouri, United States, 63110
    - Saint Louis University Cancer Center
  - Saint Louis, Missouri, United States, 63109
    - Midwest Hematology Oncology Group, Incorporated
  - Saint Louis, Missouri, United States, 63141
    - David C. Pratt Cancer Center at St. John's Mercy
  - Saint Louis, Missouri, United States, 63136
    - Christian Hospital Northeast Cancer Care Center
- Montana
  - Billings, Montana, United States, 59101
    - CCOP - Montana Cancer Consortium
  - Billings, Montana, United States, 59101
    - St. Vincent Healthcare Cancer Care Services
  - Billings, Montana, United States, 59107-7000
    - Billings Clinic - Downtown
  - Billings, Montana, United States, 59102
    - Hematology-Oncology Centers of the Northern Rockies - Billings
  - Bozeman, Montana, United States, 59715
    - Bozeman Deaconess Cancer Center
  - Butte, Montana, United States, 59701
    - St. James Healthcare Cancer Care
  - Great Falls, Montana, United States, 59405-5309
    - Big Sky Oncology
  - Great Falls, Montana, United States, 59405
    - Sletten Cancer Institute at Benefis Healthcare
  - Helena, Montana, United States, 59601
    - St. Peter's Hospital
  - Kalispell, Montana, United States, 59901
    - Kalispell Regional Medical Center
  - Kalispell, Montana, United States, 59901
    - Kalispell Medical Oncology at KRMC
  - Missoula, Montana, United States, 59807-7877
    - Montana Cancer Specialists at Montana Cancer Center
  - Missoula, Montana, United States, 59807
    - Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
- Nebraska
  - Kearney, Nebraska, United States, 68848-1990
    - Good Samaritan Cancer Center at Good Samaritan Hospital
  - Lincoln, Nebraska, United States, 68510
    - Cancer Resource Center - Lincoln
  - Omaha, Nebraska, United States, 68106
    - CCOP - Missouri Valley Cancer Consortium
  - Omaha, Nebraska, United States, 68122
    - Immanuel Medical Center
  - Omaha, Nebraska, United States, 68124
    - Alegant Health Cancer Center at Bergan Mercy Medical Center
  - Omaha, Nebraska, United States, 68131-2197
    - Creighton University Medical Center
  - Omaha, Nebraska, United States, 68130
    - Lakeside Hospital
- Nevada
  - Las Vegas, Nevada, United States, 89102
    - University Medical Center of Southern Nevada
  - Las Vegas, Nevada, United States, 89135
    - Nevada Cancer Institute
  - Las Vegas, Nevada, United States, 89106
    - CCOP - Nevada Cancer Research Foundation
- New Jersey
  - Newark, New Jersey, United States, 07103
    - UMDNJ University Hospital
  - Voorhees, New Jersey, United States, 08043
    - Cancer Institute of New Jersey at Cooper - Voorhees
- New Mexico
  - Albuquerque, New Mexico, United States, 87131-5636
    - University of New Mexico Cancer Center
  - Albuquerque, New Mexico, United States, 87106
    - Hematology Oncology Associates, PC
- New York
  - East Syracuse, New York, United States, 13057
    - CCOP - Hematology-Oncology Associates of Central New York
  - Elmira, New York, United States, 14905
    - Falck Cancer Center at Arnot Ogden Medical Center
  - Rochester, New York, United States, 14642
    - James P. Wilmot Cancer Center at University of Rochester Medical Center
- North Carolina
  - Asheville, North Carolina, United States, 28801
    - Mission Hospitals - Memorial Campus
  - Charlotte, North Carolina, United States, 28233-3549
    - Presbyterian Cancer Center at Presbyterian Hospital
  - Goldsboro, North Carolina, United States, 27534
    - Wayne Memorial Hospital, Incorporated
  - Hendersonville, North Carolina, United States, 28791
    - Pardee Memorial Hospital
  - Pinehurst, North Carolina, United States, 28374
    - FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center
  - Rutherfordton, North Carolina, United States, 28139
    - Rutherford Hospital
  - Statesville, North Carolina, United States, 28677
    - Iredell Memorial Hospital
  - Winston-Salem, North Carolina, United States, 27103
    - Forsyth Regional Cancer Center at Forsyth Medical Center
- Ohio
  - Akron, Ohio, United States, 44307
    - McDowell Cancer Center at Akron General Medical Center
  - Bowling Green, Ohio, United States, 43402
    - Wood County Oncology Center
  - Chillicothe, Ohio, United States, 45601
    - Adena Regional Medical Center
  - Cincinnati, Ohio, United States, 45267
    - Charles M. Barrett Cancer Center at University Hospital
  - Columbus, Ohio, United States, 43214-3998
    - Riverside Methodist Hospital Cancer Care
  - Columbus, Ohio, United States, 43222
    - Mount Carmel Health - West Hospital
  - Columbus, Ohio, United States, 43215
    - CCOP - Columbus
  - Columbus, Ohio, United States, 43215
    - Grant Medical Center Cancer Care
  - Columbus, Ohio, United States, 43228
    - Doctors Hospital at Ohio Health
  - Dayton, Ohio, United States, 45405
    - Grandview Hospital
  - Dayton, Ohio, United States, 45406
    - Good Samaritan Hospital
  - Dayton, Ohio, United States, 45409
    - David L. Rike Cancer Center at Miami Valley Hospital
  - Dayton, Ohio, United States, 45415
    - Samaritan North Cancer Care Center
  - Dayton, Ohio, United States, 45420
    - CCOP - Dayton
  - Delaware, Ohio, United States, 43015
    - Grady Memorial Hospital
  - Elyria, Ohio, United States, 44035
    - Community Cancer Center
  - Elyria, Ohio, United States, 44035
    - Hematology Oncology Center
  - Findlay, Ohio, United States, 45840
    - Blanchard Valley Medical Associates
  - Franklin, Ohio, United States, 45005-1066
    - Middletown Regional Hospital
  - Greenville, Ohio, United States, 45331
    - Wayne Hospital
  - Kettering, Ohio, United States, 45429
    - Charles F. Kettering Memorial Hospital
  - Lancaster, Ohio, United States, 43130
    - Fairfield Medical Center
  - Lima, Ohio, United States, 45804
    - Lima Memorial Hospital
  - Marietta, Ohio, United States, 45750
    - Strecker Cancer Center at Marietta Memorial Hospital
  - Maumee, Ohio, United States, 43537-1839
    - Northwest Ohio Oncology Center
  - Mount Vernon, Ohio, United States, 43050
    - Knox Community Hospital
  - Newark, Ohio, United States, 43055
    - Licking Memorial Cancer Care Program at Licking Memorial Hospital
  - Oregon, Ohio, United States, 43616
    - St. Charles Mercy Hospital
  - Oregon, Ohio, United States, 43616
    - Toledo Clinic - Oregon
  - Portsmouth, Ohio, United States, 45662
    - Southern Ohio Medical Center Cancer Center
  - Springfield, Ohio, United States, 45505
    - Community Hospital of Springfield and Clark County
  - Sylvania, Ohio, United States, 43560
    - Flower Hospital Cancer Center
  - Tiffin, Ohio, United States, 44883
    - Mercy Hospital of Tiffin
  - Toledo, Ohio, United States, 43608
    - St. Vincent Mercy Medical Center
  - Toledo, Ohio, United States, 43606
    - Toledo Hospital
  - Toledo, Ohio, United States, 43614
    - Medical University of Ohio Cancer Center
  - Toledo, Ohio, United States, 43617
    - CCOP - Toledo Community Hospital
  - Toledo, Ohio, United States, 43623
    - Toledo Clinic, Incorporated - Main Clinic
  - Toledo, Ohio, United States, 43623
    - St. Anne Mercy Hospital
  - Troy, Ohio, United States, 45373-1300
    - UVMC Cancer Care Center at Upper Valley Medical Center
  - Wauseon, Ohio, United States, 43567
    - Fulton County Health Center
  - Westerville, Ohio, United States, 43081
    - Mount Carmel St. Ann's Cancer Center
  - Wright-Patterson Air Force Base, Ohio, United States, 45433-5529
    - United States Air Force Medical Center - Wright-Patterson
  - Xenia, Ohio, United States, 45385
    - Ruth G. McMillan Cancer Center at Greene Memorial Hospital
  - Zanesville, Ohio, United States, 43701
    - Genesis - Good Samaritan Hospital
- Oregon
  - Clackamas, Oregon, United States, 97015
    - Clackamas Radiation Oncology Center
  - Coos Bay, Oregon, United States, 97420
    - Bay Area Hospital
  - Grants Pass, Oregon, United States, 97527
    - Three Rivers Community Hospital
  - Gresham, Oregon, United States, 97030
    - Legacy Mount Hood Medical Center
  - Medford, Oregon, United States, 97504
    - Dubs Cancer Center at Rogue Valley Medical Center
  - Medford, Oregon, United States, 97504
    - Providence Cancer Center at PMCC
  - Milwaukie, Oregon, United States, 97222
    - Providence Milwaukie Hospital
  - Newberg, Oregon, United States, 97132
    - Providence Newberg Medical Center
  - Oregon City, Oregon, United States, 97045
    - Willamette Falls Hospital
  - Portland, Oregon, United States, 97210
    - Legacy Good Samaritan Hospital & Comprehensive Cancer Center
  - Portland, Oregon, United States, 97213-2967
    - Providence Cancer Center at Providence Portland Medical Center
  - Portland, Oregon, United States, 97225
    - CCOP - Columbia River Oncology Program
  - Portland, Oregon, United States, 97225
    - Providence St. Vincent Medical Center
  - Tualatin, Oregon, United States, 97062
    - Legacy Meridian Park Hospital
- Pennsylvania
  - Allentown, Pennsylvania, United States, 18105
    - Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
  - Philadelphia, Pennsylvania, United States, 19141
    - Albert Einstein Cancer Center
- South Carolina
  - Anderson, South Carolina, United States, 29621
    - AnMed Cancer Center
  - Charleston, South Carolina, United States, 29425
    - Hollings Cancer Center at Medical University of South Carolina
  - Easley, South Carolina, United States, 29640
    - Cancer Centers of the Carolinas - Easley
  - Greenville, South Carolina, United States, 29615
    - CCOP - Greenville
  - Greenville, South Carolina, United States, 29605
    - Greenville Hospital Cancer Center
  - Greenville, South Carolina, United States, 29615
    - Cancer Centers of the Carolinas - Eastside
  - Greenville, South Carolina, United States, 29605
    - Cancer Centers of the Carolinas - Faris Road
  - Greenville, South Carolina, United States, 29605
    - Cancer Centers of the Carolinas - Grove Commons
  - Greenville, South Carolina, United States, 29601
    - Bon Secours St. Francis Health System
  - Greenwood, South Carolina, United States, 29646
    - Self Regional Cancer Center at Self Regional Medical Center
  - Greer, South Carolina, United States, 29650
    - Cancer Centers of the Carolinas - Greer Medical Oncology
  - Greer, South Carolina, United States, 29650
    - Cancer Centers of the Carolinas - Greer Radiation Oncology
  - Seneca, South Carolina, United States, 29672
    - Cancer Centers of the Carolinas - Seneca
  - Spartanburg, South Carolina, United States, 29303
    - CCOP - Upstate Carolina
  - Spartanburg, South Carolina, United States, 29303
    - Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
  - Spartanburg, South Carolina, United States, 29307
    - Cancer Centers of the Carolinas - Spartanburg
- South Dakota
  - Sioux Falls, South Dakota, United States, 57117-5039
    - Sanford Cancer Center at Sanford USD Medical Center
- Tennessee
  - Cookeville, Tennessee, United States, 38501
    - Cookeville Regional Medical Center
- Texas
  - Amarillo, Texas, United States, 79106
    - Harrington Cancer Center
  - Fort Sam Houston, Texas, United States, 78234-6200
    - Brooke Army Medical Center
  - Galveston, Texas, United States, 77555-0361
    - University of Texas Medical Branch
  - Houston, Texas, United States, 77030-4009
    - M. D. Anderson Cancer Center at University of Texas
  - Houston, Texas, United States, 77030
    - Ben Taub General Hospital
  - Houston, Texas, United States, 77030
    - Veterans Affairs Medical Center - Houston
  - Houston, Texas, United States, 77030
    - Baylor University Medical Center - Houston
  - Houston, Texas, United States, 77030
    - St. Luke's Texas Cancer Institute at St. Luke's Episcopal Hospital
  - San Antonio, Texas, United States, 78229
    - Cancer Therapy and Research Center
  - San Antonio, Texas, United States, 78209
    - Veterans Affairs Medical Center - San Antonio (Murphy)
  - San Antonio, Texas, United States, 78229-3900
    - University of Texas Health Science Center at San Antonio
  - San Antonio, Texas, United States, 78229
    - University Hospital - San Antonio
  - Temple, Texas, United States, 76508
    - CCOP - Scott and White Hospital
- Utah
  - American Fork, Utah, United States, 84003
    - American Fork Hospital
  - Cedar City, Utah, United States, 84720
    - Sandra L. Maxwell Cancer Center
  - Logan, Utah, United States, 84321
    - Logan Regional Hospital
  - Murray, Utah, United States, 84157
    - Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
  - Ogden, Utah, United States, 84403
    - Val and Ann Browning Cancer Center at McKay-Dee Hospital Center
  - Provo, Utah, United States, 84604
    - Utah Valley Regional Medical Center - Provo
  - Saint George, Utah, United States, 84770
    - Dixie Regional Medical Center - East Campus
  - Salt Lake City, Utah, United States, 84143
    - LDS Hospital
  - Salt Lake City, Utah, United States, 84112
    - Huntsman Cancer Institute at University of Utah
  - Salt Lake City, Utah, United States, 84106
    - Utah Cancer Specialists at UCS Cancer Center
- Virginia
  - Fredericksburg, Virginia, United States, 22401
    - Fredericksburg Oncology, Incorporated
- Washington
  - Anacortes, Washington, United States, 98221
    - Island Hospital Cancer Care Center at Island Hospital
  - Bellingham, Washington, United States, 98225
    - St. Joseph Cancer Center
  - Bremerton, Washington, United States, 98310
    - Olympic Hematology and Oncology
  - Burien, Washington, United States, 98166
    - Highline Medical Center Cancer Center
  - Centralia, Washington, United States, 98531-9027
    - Providence Centralia Hospital
  - Everett, Washington, United States, 98201
    - Providence Regional Cancer Partnership
  - Federal Way, Washington, United States, 98003
    - St. Francis Hospital
  - Issaquah, Washington, United States, 98029
    - Swedish Medical Center - Issaquah Campus
  - Kennewick, Washington, United States, 99336
    - Columbia Basin Hematology
  - Kirkland, Washington, United States, 98033
    - Cascade Cancer Center at Evergreen Hospital Medical Center
  - Mount Vernon, Washington, United States, 98274
    - Skagit Valley Hospital Cancer Care Center
  - Olympia, Washington, United States, 98506-5166
    - Providence St. Peter Hospital Regional Cancer Center
  - Poulsbo, Washington, United States, 98370
    - Harrison Poulsbo Hematology and Onocology
  - Puyallup, Washington, United States, 98372
    - Good Samaritan Cancer Center
  - Seattle, Washington, United States, 98109
    - Fred Hutchinson Cancer Research Center
  - Seattle, Washington, United States, 98104
    - Harborview Medical Center
  - Seattle, Washington, United States, 98101
    - Virginia Mason Medical Center
  - Seattle, Washington, United States, 98101
    - CCOP - Virginia Mason Research Center
  - Seattle, Washington, United States, 98104
    - Minor and James Medical, PLLC
  - Seattle, Washington, United States, 98112
    - Group Health Central Hospital
  - Seattle, Washington, United States, 98122-4307
    - Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
  - Seattle, Washington, United States, 98122
    - Polyclinic First Hill
  - Seattle, Washington, United States, 98195
    - University Cancer Center at University of Washington Medical Center
  - Seattle, Washington, United States, 98104
    - Pacific Medical Center
  - Sedro-Woolley, Washington, United States, 98284
    - North Puget Oncology at United General Hospital
  - Spokane, Washington, United States, 99202
    - Cancer Care Northwest - Spokane South
  - Spokane, Washington, United States, 99218
    - Evergreen Hematology and Oncology, PS
  - Tacoma, Washington, United States, 98405-3004
    - Franciscan Cancer Center at St. Joseph Medical Center
  - Tacoma, Washington, United States, 98405
    - Allenmore Hospital
  - Tacoma, Washington, United States, 98405
    - CCOP - Northwest
  - Tacoma, Washington, United States, 98405
    - MultiCare Regional Cancer Center at Tacoma General Hospital
  - Tacoma, Washington, United States, 98499
    - St. Clare Hospital
  - Vancouver, Washington, United States, 98686
    - Legacy Salmon Creek Medical Center
  - Vancouver, Washington, United States, 98664
    - Southwest Washington Medical Center Cancer Center
  - Wenatchee, Washington, United States, 98801-2028
    - Wenatchee Valley Medical Center
- Wisconsin
  - Green Bay, Wisconsin, United States, 54307-3508
    - St. Vincent Hospital Regional Cancer Center
  - Green Bay, Wisconsin, United States, 54301-3526
    - Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
  - Green Bay, Wisconsin, United States, 54303
    - Green Bay Oncology, Limited at St. Mary's Hospital
  - Green Bay, Wisconsin, United States, 54303
    - St. Mary's Hospital Medical Center - Green Bay
  - La Crosse, Wisconsin, United States, 54601
    - Gundersen Lutheran Center for Cancer and Blood
  - Manitowoc, Wisconsin, United States, 54221-1450
    - Holy Family Memorial Medical Center Cancer Care Center
  - Oconto Falls, Wisconsin, United States, 54154
    - Green Bay Oncology, Limited - Oconto Falls
  - Sheboygan, Wisconsin, United States, 53081
    - St. Nicholas Hospital
  - Sturgeon Bay, Wisconsin, United States, 54235
    - Green Bay Oncology, Limited - Sturgeon Bay
- Wyoming
  - Casper, Wyoming, United States, 82609
    - Rocky Mountain Oncology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 120 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

SWOG membership and CCOP participants through CTSU.

Description

DISEASE CHARACTERISTICS:

Participant must have bone metastasis from multiple myeloma, solid tumors, or other malignancy for which intravenous bisphosphonate has clinical indications in the treatment of metastatic bone disease
Treatment with osteoclast inhibition is clinically indicated
Must be planning to receive zoledronic acid* within the next 30 days NOTE: *Osteoclast inhibition therapy will continue thereafter as clinically indicated.
No prior diagnosis of osteonecrosis of the jaw
Patients previously treated with osteoclast inhibition therapy are eligible, provided the following criteria apply:
- Prior osteoclast inhibition for low bone mass (osteoporosis or osteopenia):
  - Patients may have previously received at most 3 doses of osteoclast-inhibiting therapy with denosumab, IV ibandronate, pamidronate, or zoledronic acid for low bone mass (osteopenia or osteoporosis) within 3 years prior to registration
  - Prior oral bisphosphonate therapy at osteoporosis or osteopenia dosing at any time prior to registration is allowed
  - Prior exposures to other medications used to treat low bone mass at osteoporosis or osteopenia dosing are permitted
- Prior osteoclast inhibition for metastatic bone disease (tumor involving bone):
  - Patients may have previously received osteoclast-inhibiting therapy with denosumab, ibandronate (oral or IV cancer dosing), pamidronate, or zoledronic acid to treat metastatic bone disease within 180 days prior to registration
    - Patients receiving these regimens for metastatic bone disease prior to 180 days before registration are not eligible
- Prior osteoclast-inhibiting therapy at higher dosing than outlined above at any time prior to registration is not allowed

PATIENT CHARACTERISTICS:

Zubrod performance status 0-3
- Patients who may be acutely ill from spinal cord compromise, hypercalcemia of malignancy, or other process may be study candidates once the acute condition has been addressed and performance status improves to 0-3
Not pregnant or nursing
Negative pregnancy test
Willing and physically able to comply with study procedures and assessments
Willing to provide information on personal history, including tobacco and alcohol use, and pain assessment
Willing to provide access to prior and future dental information
No other prior malignancy except for any of the following:
- Adequately treated basal cell carcinoma or squamous cell carcinoma of the skin
- In situ cervical cancer
- Adequately treated stage I or II cancer for which the patient is currently in complete remission
- Any other cancer for which the patient has been disease-free for 5 years

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
No history of radiation to the maxillofacial area administered for therapeutic intent in the treatment of cancer
Concurrent participation in other therapeutic and non-therapeutic clinical trials allowed
The sum of prior IV bisphosphonate doses must not be greater than 10
The sum of prior denosumab doses must not be greater than 8
The total of both IV bisphosphonate and denosumab used for any indication must not be greater than 12 doses

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Observation Patients will be observed and will undergo assessment of therapy complications.	Procedure: assessment of therapy complications By dental and medical assessments.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Diagnosis of confirmed osteonecrosis of the jaw (ONJ) Time Frame: 3 years	3 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Disease-specific estimates of the confirmed cumulative incidence at 3 years of ONJ Time Frame: 3 years	3 years
Clinical presentation and natural history of ONJ Time Frame: 3 years	3 years
Overall and disease-specific cumulative incidence Time Frame: 3 years	3 years
Association of baseline factors with cumulative incidence of confirmed ONJ Time Frame: 3 years	3 years
Association between patient-related outcomes and confirmed incidence Time Frame: 3 years	3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Southwest Oncology Group

Collaborators

National Cancer Institute (NCI)

Novartis

Investigators

Study Chair: Julie R. Gralow, MD, Seattle Cancer Care Alliance
Study Chair: Catherine Van Poznak, MD, University of Michigan Rogel Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Van Poznak CH, Darke A, Moinpour CM, Bagramian RA, Schubert MM, Gralow JR, Wade JL 3rd, Unger JM. Dental health status and patient-reported outcomes at baseline in patients participating in the osteonecrosis of the jaw registry study, SWOG S0702. Support Care Cancer. 2017 Apr;25(4):1191-1199. doi: 10.1007/s00520-016-3509-3. Epub 2016 Dec 7.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2008

Primary Completion (Actual)

June 1, 2019

Study Completion (Actual)

June 1, 2019

Study Registration Dates

First Submitted

April 1, 2009

First Submitted That Met QC Criteria

April 1, 2009

First Posted (Estimate)

April 2, 2009

Study Record Updates

Last Update Posted (Actual)

July 5, 2019

Last Update Submitted That Met QC Criteria

July 3, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

S0702 (Other Identifier: SWOG)
U10CA037429 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Actual)

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Genders Eligible for Study

Sampling Method

Study Population

Description

Study Plan

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Time Frame

Secondary Outcome Measures

Outcome Measure

Time Frame

Collaborators and Investigators

Sponsor

Collaborators

Investigators

Publications and helpful links

General Publications

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Estimate)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

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Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Clinical Trials on Breast Cancer

Clinical Trials on assessment of therapy complications

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Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mauritius

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations