Clinical Research Details

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

The primary objective of this study is to prospectively assess the cumulative incidence of osteonecrosis of the jaw (ONJ) at three years in cancer participants with bone metastasis receiving zoledronic acid treatment.

201543021809

7000

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.
All participants must be planning to receive zoledronic acid (as their sole bisphosphonate therapy) within 30 days after registration. (NOTE: Bisphosphonate therapy will continue thereafter as clinically indicated.) Patients previously treated with bisphosphonate therapy are eligible if the following criteria apply:
-Participants 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
-Participants may have received intravenous bisphosphonate therapy with
ibandronate, pamidronate or zoledronic acid to treat metastatic bone disease
within 90 days prior to registration. Participants receiving any of these regimens
for metastatic bone disease prior to 90 days before registration are not
eligible, or prior oral bisphosphonate therapy at any time prior to registration is allowed.
-Participants must not have a pre-existing diagnosis of ONJ.
-Participants must not have a history of radiation to the maxillofacial area administered for therapeutic intent in the treatment of cancer.
-Participants must have a Zubrod performance status of 0-3 (see Section 10.2).
NOTE: Participants 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.
-Participants must be willing and physically able to comply with the study procedures and assessments.
-Participantss must be offered the option to submit blood for banking and DNA analysis, as specified in Section 15.0.
-Participants must be willing to provide information on history, including tobacco and alcohol use, symptoms, and pain assessment.
are required to undergo a baseline dental exam. The dental exam must occur
within 6 months prior to registration. The baseline dental exam is to include: dental
history, dental exam, periodontal exam and dental imaging. Panoramic x-ray is the
preferred imaging technique, although other imaging modalities such as intraoral fims (small films), bite wings, x-rays films and/or digital files may be appropriate for some individuals. Dental imaging within 12 months prior to registration is acceptable. The S0702 Dentist Contact Form and S0702 Dental Assessment Form (related to the baseline dental exam) must be completed by the Dental Health Professional and returned to the registering institution prior to registration.
-Participants must be willing to provide access to prior and future dental information
-Participants can concurrently participate in other therapeutic and non-therapeutic clinical trials.

This is not a treatment study. This study involves collecting information about your treatment with zoledronic acid and collecting information about your general health and medical history, oral health and dental history and pain assessment through questionnaires. Most importantly, we will collect information about ONJ if it occurs and what kind of treatment you receive for ONJ.

Kathy S. Albain, M.D.

(708) 327-3229