Clinical Trial: Osteonecrosis of the Jaw (ONJ) Case Registry

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational

Official Title: Osteonecrosis of the Jaw (ONJ) Case Registry

Brief Summary: Osteonecrosis of the Jaw (ONJ) Case Registry

Detailed Summary: 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.
Sponsor: Amgen

Current Primary Outcome: Resolution rate and time to ONJ resolution [ Time Frame: 5 years ]

Original Primary Outcome: Resolution rate and time to ONJ resolution [ Time Frame: 5 years ]

Measuring the rate and estimating the time course of resolution of onj using the following definitions: - 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


Current Secondary Outcome:

  • The clinical features of ONJ, including severity and staging at enrollment [ Time Frame: 5 years ]
  • The frequency of risk factors for incident ONJ [ Time Frame: 5 years ]
  • Therapeutic treatment patterns for ONJ [ Time Frame: 5 years ]
  • Treatment patterns of antiresorptive agents subsequent to incident ONJ [ Time Frame: 5 years ]


Original Secondary Outcome:

  • Explore the relationship between rate and time to ONJ resolution with ONJ severity and staging at Registry enrollment [ Time Frame: 5 years ]
    The Registry will use the following scales: AAOMS ONJ Staging (Adapted from Ruggiero et al, 2009); ONJ Severity (CTCAE 4.03) ONJ Lesion Size Grading (Weitzman et al 2007)
  • Explore the relationship between rate and time to ONJ resolution with potential risk factors [ Time Frame: 5 years ]
    History of inflammatory dental disease, dentoalveolar procedures, smoking, use of anti-angiogenic agents, and duration/dosing regimens of antiresorptive agents prior to ONJ
  • Explore the relationship between rate and time to ONJ resolution and subsequent treatment patterns for ONJ including antibiotics, anti-microbial rinses and surgery [ Time Frame: 5 years ]
  • Explore the relationship between rate and time to ONJ resolution and treatment patterns of antiresorptive therapy [ Time Frame: 5 years ]


Information By: Amgen

Dates:
Date Received: June 22, 2012
Date Started: October 2012
Date Completion: April 2021
Last Updated: December 21, 2016
Last Verified: December 2016