Osteonecrosis of the Jaw (ONJ) Case Registry

Completed

• Conditions: Osteonecrosis of the Jaw

• Registration Number: NCT01666106
• Lead Sponsor: Amgen

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.

Study Timeline

• Study First Submitted: 2012-06-22
• Study First Submitted QC: 2012-08-14
• Study First Posted: 2012-08-16
• Study Start: 2012-10-01
• Status Verified: 2020-12
• Primary Completion: 2020-12-16
• Study Completion: 2020-12-16
• Last Update Submitted: 2020-12-18
• Last Update Posted: 2020-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 327

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Resolution rate and time to ONJ resolution	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 Outcome Measures

Name	Time	Method
The clinical features of ONJ, including severity and staging at enrollment	5 years
The frequency of risk factors for incident ONJ	5 years	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
Therapeutic treatment patterns for ONJ	5 years	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
Treatment patterns of antiresorptive agents subsequent to incident ONJ	5 years	Characterize subsequent treatment patterns for ONJ including antimicrobial oral rinses, antibiotics, and surgery

Trial Locations

Locations (1)

Research Site; 🇬🇧 Sheffield, United Kingdom