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Osteonecrosis of the Jaw (ONJ) Case Registry

18 Years
Open (Enrolling)
Osteonecrosis of the Jaw (ONJ)

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Trial Information

Osteonecrosis of the Jaw (ONJ) Case Registry

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.

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

Exclusion Criteria:

- History of radiation to the maxillofacial area administered for therapeutic intent in
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.

Type of Study:


Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Resolution rate and time to ONJ resolution

Outcome Time Frame:

5 years

Safety Issue:


Principal Investigator


Investigator Role:

Study Director

Investigator Affiliation:



Belgium: Federal Agency for Medicinal Products and Health Products

Study ID:




Start Date:

October 2012

Completion Date:

March 2021

Related Keywords:

  • Osteonecrosis of the Jaw (ONJ)
  • Osteonecrosis



Research Site Anaheim, California  
Research Site Boulder, Colorado  
Research Site Washington, District of Columbia  
Research Site Boca Raton, Florida  
Research Site Albany, Georgia  
Research Site Arlington Heights, Illinois  
Research Site Ames, Iowa  
Research Site Baltimore, Maryland  
Research Site Grand Island, Nebraska  
Research Site Albany, New York  
Research Site Asheville, North Carolina  
Research Site Chattanooga, Tennessee  
Research Site Abilene, Texas