Osteonecrosis of the Jaw (ONJ) Case Registry

Study type

• Study topic:
  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology

  Drug utilisation

  Safety study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Case-series, Post-Marketing Safety Study

Study drug and medical condition

• Medical condition to be studied:
  Osteonecrosis of jaw

Population studied

• Short description of the study population:
  Investigators will be expected to maintain a screening log of all potential study candidates that includes limited information about the potential candidate such as sex, age, race, screening date, and outcome of the screening process (eg, enrolled into study, reason for ineligibility [eg, ONJ not positively adjudicated], or declined to participate). The rate of nonparticipation will be monitored during the trial. Before any study-specific procedure, the appropriate written informed consent will be obtained; Inclusion Criteria; 1. Adult (≥ 18 years of age) with diagnosis of cancer; 2. Newly diagnosed, positively-adjudicated ONJ; 3. ECOG ≤ 2 and expected survival ≥ 3 months; 4. Willing to provide access to previous and future medical and dental information; 5. Subject or subject’s legally acceptable representative has provided written informed consent; ; Exclusion Criteria; 1. History of radiation to the jaws administered for the treatment of cancer; 2. Subject will not be available for protocol-required study visits, to the best of the subject and investigator’s knowledge; 3. 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
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Cancer patients
• Estimated number of subjects:
  327

Study design details

• Main study objective:
  To describe the natural history of positively-adjudicated ONJ in subjects with cancer with a 5-yr. observation period. Most of these subjects are expected to have received bone antiresorptive agents such as bisphosphonates or denosumab together with cancer-specific therapies. The registry may also include subjects with cancer who developed ONJ without exposure to any antiresorptive therapy.
• Outcomes:
  Resolution rate and time to ONJ resolution Time Frame: 5 years , Explore the relationship between rate and time to ONJ resolution with the following:ONJ severity and staging at Registry enrollment 5 yrs potential risk factors 5 yrs Explore the relationship between rate and time to ONJ resolution and the following:subsequent treatment patterns for ONJ 5 yrstreatment patterns of antiresorptive therapy 5 yrs
• Data analysis plan:
  The objective of this study is to describe the natural history of positively-adjudicated ONJ in subjects with cancer. The primary endpoint is ONJ resolution and time course of resolution. Secondary endpoints include the clinical features of ONJ, including severity and staging at enrolment and the frequency of risk factors for incident ONJ. Continuous parameters will be summarized using descriptive statistics, which includes mean, standard deviation, median, and/or selected percentiles, and the number of non-missing observations. Categorical parameters will be summarized using frequencies and percentages. In general, analyses will be based on available data.

Documents

Study results

20101102_Observational_Research_Study_Report_Published_Report_Summary