Status
Conditions
Treatments
Study type
Funder types
Identifiers
About
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.
Full description
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients undergo dental assessments at baseline and every 3-6 months for 3 years.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
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:
3,571 participants in 1 patient group
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal