Osteonecrosis of the Jaw (ONJ) Case Registry

Amgen327 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

327

Conditions

Osteonecrosis of the Jaw

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (64)

Outcomes

Primary Outcomes

Resolution rate and time to ONJ resolution

* 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

Time frame: 5 years

Secondary Outcomes

The clinical features of ONJ, including severity and staging at enrollment

Time frame: 5 years

The frequency of risk factors for incident ONJ

Characterize the frequency of risk factors for incident ONJ such as a history of inflammatory dental disease (periodontal and dental abscesses), dentoalveolar procedures, smoking, use of antiangiogenic agents, and duration/dosing regimens of antiresorptive medications prior to the development of ONJ

Time frame: 5 years

Therapeutic treatment patterns for ONJ

Characterize treatment patterns of antiresorptive medications subsequent to incident ONJ such as the proportion of subjects who continue to be treated with antiresorptive medications by specific agents and ONJ severity and stage

Time frame: 5 years

Treatment patterns of antiresorptive agents subsequent to incident ONJ

Characterize subsequent treatment patterns for ONJ including antimicrobial oral rinses, antibiotics, and surgery

Time frame: 5 years

Data from ClinicalTrials.gov

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Research Site

Beverly Hills, California, United States

Research Site

Duarte, California, United States

Research Site

Denver, Colorado, United States

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Farmington, Connecticut, United States

Research Site

Stratford, Connecticut, United States

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Washington D.C., District of Columbia, United States

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Gainesville, Florida, United States

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Atlanta, Georgia, United States

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Chicago, Illinois, United States

Research Site

Council Bluffs, Iowa, United States

...and 54 more locations