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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

Open (Enrolling)
Breast Cancer, Lung Cancer, Metastatic Cancer, Multiple Myeloma, Plasma Cell Neoplasm, Prostate Cancer, Unspecified Adult Solid Tumor, Protocol Specific

Thank you

Trial Information

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



- 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.


- 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.

Inclusion Criteria


- 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

- 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


- 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


- 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

- 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

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Diagnosis of confirmed osteonecrosis of the jaw (ONJ)

Outcome Time Frame:

3 years

Safety Issue:


Principal Investigator

Catherine Van Poznak, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Michigan Cancer Center


United States: Federal Government

Study ID:




Start Date:

December 2008

Completion Date:

April 2015

Related Keywords:

  • Breast Cancer
  • Lung Cancer
  • Metastatic Cancer
  • Multiple Myeloma
  • Plasma Cell Neoplasm
  • Prostate Cancer
  • Unspecified Adult Solid Tumor, Protocol Specific
  • bone metastases
  • unspecified adult solid tumor, protocol specific
  • refractory multiple myeloma
  • stage I multiple myeloma
  • stage II multiple myeloma
  • stage III multiple myeloma
  • male breast cancer
  • recurrent breast cancer
  • stage IA breast cancer
  • stage IB breast cancer
  • stage II breast cancer
  • stage IIIA breast cancer
  • stage IIIB breast cancer
  • stage IIIC breast cancer
  • stage IV breast cancer
  • recurrent prostate cancer
  • stage I prostate cancer
  • stage IIB prostate cancer
  • stage IIA prostate cancer
  • stage III prostate cancer
  • stage IV prostate cancer
  • recurrent non-small cell lung cancer
  • stage I non-small cell lung cancer
  • stage II non-small cell lung cancer
  • stage IIIA non-small cell lung cancer
  • stage IIIB non-small cell lung cancer
  • stage IV non-small cell lung cancer
  • extensive stage small cell lung cancer
  • limited stage small cell lung cancer
  • recurrent small cell lung cancer
  • Breast Neoplasms
  • Neoplasms
  • Lung Neoplasms
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Plasmacytoma
  • Neoplasm Metastasis
  • Neoplasms, Second Primary
  • Osteonecrosis
  • Prostatic Neoplasms
  • Bone Neoplasms
  • Bone Marrow Diseases



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Good Samaritan Cancer Center Puyallup, Washington  98371
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Highland General Hospital Oakland, California  94602
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida Tampa, Florida  33612
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Saint Luke's Hospital - South Overland Park, Kansas  66213
Cancer Center of Kansas, PA - Parsons Parsons, Kansas  67357
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Tammy Walker Cancer Center at Salina Regional Health Center Salina, Kansas  67401
Cancer Center of Kansas, PA - Salina Salina, Kansas  67401
Cotton-O'Neil Cancer Center Topeka, Kansas  66606
Cancer Center of Kansas, PA - Wellington Wellington, Kansas  67152
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Seton Cancer Institute at Saint Mary's - Saginaw Saginaw, Michigan  48601
Lakeside Cancer Specialists, PLLC Saint Joseph, Michigan  49085
Willmar Cancer Center at Rice Memorial Hospital Willmar, Minnesota  56201
Heartland Hematology Oncology Associates, Incorporated Kansas City, Missouri  64118
North Kansas City Hospital Kansas City, Missouri  64116
Saint Luke's Cancer Institute at Saint Luke's Hospital Kansas City, Missouri  64111
Research Medical Center Kansas City, Missouri  64132
Saint Luke's East - Lee's Summit Lee's Summit, Missouri  64086
Heartland Regional Medical Center Saint Joseph, Missouri  64506
Saint Joseph Oncology, Incorporated Saint Joseph, Missouri  64507
Billings Clinic - Downtown Billings, Montana  59107-7000
Bozeman Deaconess Cancer Center Bozeman, Montana  59715
St. James Healthcare Cancer Care Butte, Montana  59701
Sletten Cancer Institute at Benefis Healthcare Great Falls, Montana  59405
Kalispell Medical Oncology at KRMC Kalispell, Montana  59901
Alegant Health Cancer Center at Bergan Mercy Medical Center Omaha, Nebraska  68124
Grant Medical Center Cancer Care Columbus, Ohio  43215
Hematology Oncology Center Elyria, Ohio  44035
Community Cancer Center Elyria, Ohio  44035
Wayne Hospital Greenville, Ohio  45331
Knox Community Hospital Mount Vernon, Ohio  43050
Flower Hospital Cancer Center Sylvania, Ohio  43560
St. Anne Mercy Hospital Toledo, Ohio  43623
Mount Carmel St. Ann's Cancer Center Westerville, Ohio  43081
Legacy Good Samaritan Hospital & Comprehensive Cancer Center Portland, Oregon  97210
Sandra L. Maxwell Cancer Center Cedar City, Utah  84720
Jon and Karen Huntsman Cancer Center at Intermountain Medical Center Murray, Utah  84157
Val and Ann Browning Cancer Center at McKay-Dee Hospital Center Ogden, Utah  84403
Fredericksburg Oncology, Incorporated Fredericksburg, Virginia  22401
St. Joseph Cancer Center Bellingham, Washington  98225
Providence Centralia Hospital Centralia, Washington  98531-9027
Columbia Basin Hematology Kennewick, Washington  99336
Harrison Poulsbo Hematology and Onocology Poulsbo, Washington  98370
Evergreen Hematology and Oncology, PS Spokane, Washington  99218
Franciscan Cancer Center at St. Joseph Medical Center Tacoma, Washington  98405-3004
Legacy Salmon Creek Medical Center Vancouver, Washington  98686
Wenatchee Valley Medical Center Wenatchee, Washington  98801-2028
Rocky Mountain Oncology Casper, Wyoming  82609
FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center Pinehurst, North Carolina  28374
Regional Cancer Center at Memorial Medical Center Springfield, Illinois  62781-0001
Saint Louis University Cancer Center Saint Louis, Missouri  63110
John H. Stroger, Jr. Hospital of Cook County Chicago, Illinois  60612-9985
Ben Taub General Hospital Houston, Texas  77030
St. Joseph Hospital Regional Cancer Center - Orange Orange, California  92868-3849
Queen's Cancer Institute at Queen's Medical Center Honolulu, Hawaii  96813
Good Samaritan Cancer Center at Good Samaritan Hospital Kearney, Nebraska  68848-1990
Pardee Memorial Hospital Hendersonville, North Carolina  28791
Rutherford Hospital Rutherfordton, North Carolina  28139
Three Rivers Community Hospital Grants Pass, Oregon  97527
Dubs Cancer Center at Rogue Valley Medical Center Medford, Oregon  97504
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center Spartanburg, South Carolina  29303
Union Hospital of Cecil County Elkton MD, Maryland  21921
Greenville Hospital Cancer Center Greenville, South Carolina  29605
Cancer Centers of the Carolinas - Grove Commons Greenville, South Carolina  29605
Cancer Centers of the Carolinas - Faris Road Greenville, South Carolina  29605
Cancer Centers of the Carolinas - Greer Medical Oncology Greer, South Carolina  29650
Cancer Centers of the Carolinas - Seneca Seneca, South Carolina  29672
Cancer Centers of the Carolinas - Spartanburg Spartanburg, South Carolina  29307
Sherman Hospital Elgin, Illinois  60120-2198
Cancer Centers of the Carolinas - Eastside Greenville, South Carolina  29601
Providence Cancer Center Anchorage, Alaska  99508
Lacks Cancer Center at Saint Mary's Health Care Grand Rapids, Michigan  49503
Doctors Medical Center - San Pablo Campus San Pablo, California  94806
St. Vincent Healthcare Cancer Care Services Billings, Montana  59101
Parvin Radiation Oncology Kansas City, Missouri  64116
Midwest Hematology Oncology Group, Incorporated Saint Louis, Missouri  63109
Providence Cancer Center at Providence Hospital Mobile, Alabama  36608
East Bay Radiation Oncology Center Castro Valley, California  94546
Contra Costa Regional Medical Center Martinez, California  94553-3156
Tibotec Therapeutics - Division of Ortho Biotech Products, LP Marysville, California  95901
El Camino Hospital Cancer Center Mountain View, California  94040
Larry G Strieff MD Medical Corporation Oakland, California  94609
Tom K Lee, Incorporated Oakland, California  94609
Bay Area Breast Surgeons, Incorporated Oakland, California  94609
Valley Medical Oncology Consultants - Pleasanton Pleasanton, California  94588
Tahoe Forest Cancer Center Truckee, California  96161
Kapiolani Medical Center at Pali Momi Aiea, Hawaii  96701
Kapiolani Medical Center for Women and Children Honolulu, Hawaii  96826
Straub Clinic and Hospital, Incorporated Honolulu, Hawaii  96813
Hawaii Medical Center - East Honolulu, Hawaii  96817
OnCare Hawaii, Incorporated - Kuakini Honolulu, Hawaii  96817
OnCare Hawaii, Incorporated - Lusitana Honolulu, Hawaii  96813
Maui Memorial Medical Center Wailuku, Hawaii  96793
Pacific Cancer Institute - Maui Wailuku, Hawaii  96793
Trinity Cancer Center at Trinity Medical Center - 7th Street Campus Moline, Illinois  61265
Mercy General Health Partners Muskegon, Michigan  49443
Christian Hospital Northeast Cancer Care Center Saint Louis, Missouri  63136
United States Air Force Medical Center - Wright-Patterson Wright-Patterson AFB, Ohio  45433-5529
Bay Area Hospital Coos Bay, Oregon  97420
AnMed Cancer Center Anderson, South Carolina  29621
Providence Cancer Center at PMCC Medford, Oregon  97504
Hematology Oncology Associates, PC Albuquerque, New Mexico  87106
Regional Medical Center Anniston, Alabama  36202
Valley Medical Oncology Consultants - Castro Valley Castro Valley, California  94546
Valley Medical Oncology Fremont, California  94538
Memorial Hospital Cancer Center - Colorado Springs Colorado Springs, Colorado  80909
Ochsner Health Center - Covington Covington, Louisiana  70433
Cancer Care Center at John Muir Health - Concord Campus Concord, California  94524-4110
St. Luke's Texas Cancer Institute at St. Luke's Episcopal Hospital Houston, Texas  77030
Cancer Centers of the Carolinas - Easley Easley, South Carolina  29640
Self Regional Cancer Center at Self Regional Medical Center Greenwood, South Carolina  29646
Cancer Centers of the Carolinas - Greer Radiation Oncology Greer, South Carolina  29650
Minnesota Oncology - Maplewood Maplewood, Minnesota  55109
Humphrey Cancer Center at North Memorial Outpatient Center Robbinsdale, Minnesota  55422-2900
Lakeview Hospital Stillwater, Minnesota  55082
Minnesota Oncology - Woodbury Woodbury, Minnesota  55125
Caritas Holy Family Hospital Methuen, Massachusetts  01844
Falck Cancer Center at Arnot Ogden Medical Center Elmira, New York  14905
CCOP - Kansas City Prairie Village, Kansas  66208
Nevada Cancer Institute Las Vegas, Nevada  89135
Sierra Nevada Cancer Center at Sierra Nevada Memorial Hospital Grass Valley, California  95945
Piedmont Fayette Hospital Fayetteville, Georgia  30214
Kauai Medical Clinic Lihue, Hawaii  96766
Central Dupage Cancer Center Warrenville, Illinois  60555
Clemens Regional Medical Center Mount Clemens, Michigan  48043
Southeast Cancer Center Cape Girardeau, Missouri  63703
Goldschmidt Cancer Center Jefferson City, Missouri  65109
Lakeside Hospital Omaha, Nebraska  68130
Clackamas Radiation Oncology Center Clackamas, Oregon  97015
Providence Newberg Medical Center Newberg, Oregon  97132
Willamette Falls Hospital Oregon City, Oregon  97045
Island Hospital Cancer Care Center at Island Hospital Anacortes, Washington  98221
Highline Medical Center Cancer Center Burien, Washington  98166
Littleton Adventist Hospital Littleton, Colorado  80122
Parker Adventist Hospital Parker, Colorado  80138
New Ulm Medical Center New Ulm, Minnesota  56073
St. Nicholas Hospital Sheboygan, Wisconsin  53081
Pacific Medical Center Seattle, Washington  98104
Saint Luke's Mountain States Tumor Institute Boise, Idaho  83712
Highland Clinic Shreveport, Louisiana  71105
Space Coast Medical Associates Cocoa Beach, Florida  32931
Breastlink Medical Group, Incorporated at Long Beach Memorial Medical Center Long Beach, California  90806
Southern Ohio Medical Center Cancer Center Portsmouth, Ohio  45662
McLaren Cancer Institute Flint, Michigan  48532
Cookeville Regional Medical Center Cookeville, Tennessee  38501
Saint Luke's Mountain States Tumor Institute - Fruitland Fruitland, Idaho  83619
Mountain States Tumor Institute - Meridian Meridian, Idaho  83642
Mountain States Tumor Institute at St. Luke's Twin Falls, Idaho  83301
Spectrum Health Reed City Hospital Reed City, Michigan  49677
Providence Regional Cancer Partnership Everett, Washington  98201
Cancer Center of Kansas, PA - McPherson McPherson, Kansas  67460
St. Joseph Regional Medical Center Lewiston, Idaho  83501
Sacred Heart Medical Oncology Pensacola, Florida  32504
Swedish Medical Center - Issaquah Campus Issaquah, Washington  98029
Epic Care - Oakland Oakland, California  94612
Singh and Arora Hematology Oncology, PC Flint, Michigan  48532
Great Lakes Cancer Institute - Lapeer Campus Lapeer, Michigan  48446
NEA Medical Clinic - East Matthews Jonesboro, Arkansas  72401
Mercy Cancer Center at Mercy Medical Center Merced, California  95340
Memorial Hospital of Carbondale Carbondale, Illinois  62902
Delnor Hospital - Geneva Geneva, Illinois  60134