Osteonecrosis of the Jaw (ONJ) Case Registry

Amgen

Status: Completed

Conditions: Osteonecrosis of the Jaw

Study type: Observational

Funder types: Industry

Identifiers

NCT01666106

20101102

Details and patient eligibility

About

Osteonecrosis of the Jaw (ONJ) Case Registry

Full 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.

Enrollment: 327 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

327 participants in 1 patient group

Subjects with cancer and ONJ

Description:

Subjects with cancer and positively adjudicated ONJ