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
English (288.89 KB - PDF)View document