Prospective Observational Multi Central Cohort Study to Assess the Incidence of Osteo Necrosis of Jaw in Patients With Bone Metastasis Starting Zoledronic Acid Treatment
1. Bone metastasis from multiple myeloma, solid tumors, or other malignancy for which
intravenous bisphosphonate has clinical indications in the treatment of metastatic
2. All participants must be planning to receive zoledronic acid (as their sole
bisphosphonate therapy) within 30 days after registration. Patients previously
treated with bisphosphonate therapy are eligible if the following criteria apply:
1. Patients may have previously received at most 3 doses of intravenous
bisphosphonate therapy with ibandronate, pamidronate or zoledronic acid for low
bone mass (osteopenia or osteoporosis) within 3 years prior to registration or
2. Patients may have received intravenous bisphosphonate therapy with ibandronate,
pamidronate or zoledronic acid to treat metastatic bone disease within 90 days
prior to registration. Patients receiving any of these regimens for metastatic
bone disease prior to 90 days before registration are not eligible, or c. Prior
oral bisphosphonate therapy at any time prior to registration is allowed.
3. No pre-existing diagnosis of ONJ.
4. No history of radiation to the maxillofacial area administered for therapeutic intent
in the treatment of cancer.
5. Zubrod performance status of 0-3.
6. Willing and physically able to comply with the study procedures and assessments.
7. Can concurrently participate in other therapeutic and non-therapeutic clinical
8. No other prior malignancy is allowed except for the following: adequately treated
basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated
Stage I or II cancer from which the patient is currently in complete remission, or
any other cancer from which the patient has been disease-free for 5 years.
9. Must be informed of the investigational nature of this study and must sign and give
written informed consent.