Osteonecrosis of the Jaw (ONJ) Case Registry
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Osteonecrosis of the Jaw
- Sponsor
- Amgen
- Enrollment
- 327
- Locations
- 1
- Primary Endpoint
- Resolution rate and time to ONJ resolution
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
Osteonecrosis of the Jaw (ONJ) Case Registry
Detailed Description
The purpose of the ONJ case registry is to describe the natural history of positively-adjudicated ONJ in subjects with cancer with an observation period of 5 years. Most of these subjects are expected to have received bone antiresorptive agents such as bisphosphonates or denosumab together with cancer-specific therapies (eg, chemotherapy, steroids, or anti-angiogenics). It is also possible that the registry will include subjects with cancer who developed ONJ without exposure to any antiresorptive therapy.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Adult (≥18 years of age) with diagnosis of cancer
- •Newly diagnosed, positively-adjudicated ONJ
- •ECOG \<=2 and expected survival ≥3 months
- •Willing to provide access to previous and future medical and dental information
- •Subject or subject's legally acceptable representative has provided written informed consent
Exclusion Criteria
- •History of radiation to the jaws administered for the treatment of cancer
- •Subject will not be available for protocol required study visits, to the best of the subject and investigator's knowledge.
- •Subject has any kind of disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent and/or to comply with all required study procedures.
Outcomes
Primary Outcomes
Resolution rate and time to ONJ resolution
Time Frame: 5 years
* Resolution: complete coverage of the exposed bone by mucosa in the absence of clinical symptoms * Improvement: a decrease in the stage or severity of the lesion * Progression: an increase in the stage or severity of the lesion * Stable: not resolved, improved, or progressed
Secondary Outcomes
- The clinical features of ONJ, including severity and staging at enrollment(5 years)
- The frequency of risk factors for incident ONJ(5 years)
- Therapeutic treatment patterns for ONJ(5 years)
- Treatment patterns of antiresorptive agents subsequent to incident ONJ(5 years)