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
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.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients undergo dental assessments at baseline and every 3-6 months for 3 years.
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):
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
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
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:
PRIOR CONCURRENT THERAPY:
Fairbanks, Alaska 99701, United States
Little Rock, Arkansas 72205, United States
Concord, California 94524-4110, United States
Grass Valley, California 95945, United States
Long Beach, California 90806, United States
Los Angeles, California 90089-9181, United States
Marysville, California 95901, United States
Grand Junction, Colorado 81502, United States
Hartford, Connecticut 06105, United States
Tampa, Florida 33612-9497, United States
Savannah, Georgia 31403-3089, United States
Valdosta, Georgia 31602, United States
Boise, Idaho 83706, United States
Boise, Idaho 83712, United States
Maywood, Illinois 60153, United States
Moline, Illinois 61265, United States
Beech Grove, Indiana 46107, United States
La Porte, Indiana 46350, United States
Des Moines, Iowa 50309, United States
Des Moines, Iowa 50314, United States
Wichita, Kansas 67214, United States
Shreveport, Louisiana 71130-3932, United States
Dearborn, Michigan 48123-2500, United States
Grosse Pointe Woods, Michigan 48236, United States
Southfield, Michigan 48075, United States
Minneapolis, Minnesota 55407, United States
Robbinsdale, Minnesota 55422-2900, United States
Billings, Montana 59102, United States
Missoula, Montana 59807, United States
Voorhees Township, New Jersey 08043, United States
East Syracuse, New York 13057, United States
Rochester, New York 14642, United States
Charlotte, North Carolina 28233-3549, United States
Pinehurst, North Carolina 28374, United States
Winston-Salem, North Carolina 27103, United States
Wright-Patterson Air Force Base, Ohio 45433-5529, United States
Portland, Oregon 97213-2967, United States
Allentown, Pennsylvania 18105, United States
Charleston, South Carolina 29425, United States
Greenwood, South Carolina 29646, United States
Greer, South Carolina 29650, United States
Spartanburg, South Carolina 29303, United States
Sioux Falls, South Dakota 57117-5039, United States
Houston, Texas 77030, United States
San Antonio, Texas 78229-3900, United States
Murray, Utah 84157, United States
Seattle, Washington 98122-4307, United States
Seattle, Washington 98195, United States
Green Bay, Wisconsin 54301-3526, United States
Manitowoc, Wisconsin 54221-1450, United States