Osteonecrosis of the Jaw (ONJ) Case Registry

December 18, 2020 updated by: Amgen
Osteonecrosis of the Jaw (ONJ) Case Registry

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
327

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Bruxelles, Belgium, 1000
        • Research Site
      • Edegem, Belgium, 2650
        • Research Site
      • Leuven, Belgium, 3000
        • Research Site
  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y4
        • Research Site
    • Ontario
      • Kitchener, Ontario, Canada, N2N 2B9
        • Research Site
      • Sault Ste. Marie, Ontario, Canada, P6B 0A8
        • Research Site
      • Sudbury, Ontario, Canada, P3E 5J1
        • Research Site
    • Quebec
      • Québec, Quebec, Canada, G1S 4L8
        • Research Site
  • Denmark
      • Aarhus C, Denmark, 8000
        • Research Site
      • Kobenhavn O, Denmark, 2100
        • Research Site
  • Finland
      • Helsinki, Finland, 00029
        • Research Site
      • Kuopio, Finland, 70211
        • Research Site
      • Oulu, Finland, 90029
        • Research Site
  • France
      • Bordeaux, France, 33075
        • Research Site
      • Brest Cedex 2, France, 29609
        • Research Site
      • Lyon, France, 69008
        • Research Site
      • Paris Cedex 13, France, 75651
        • Research Site
      • Saint Herblain, France, 44800
        • Research Site
  • Germany
      • Berlin, Germany, 12200
        • Research Site
      • Berlin, Germany, 13055
        • Research Site
      • Düsseldorf, Germany, 40225
        • Research Site
      • Köln, Germany, 50677
        • Research Site
      • Mühlhausen, Germany, 99974
        • Research Site
      • München, Germany, 80337
        • Research Site
      • München, Germany, 80335
        • Research Site
      • Regensburg, Germany, 93053
        • Research Site
  • Greece
      • Athens, Greece, 11527
        • Research Site
      • Athens, Greece, 11528
        • Research Site
      • Thessaloniki, Greece, 54121
        • Research Site
      • Thessaloniki, Greece, 57010
        • Research Site
  • Italy
      • Alessandria, Italy, 15121
        • Research Site
      • Brescia, Italy, 25123
        • Research Site
      • Lecce, Italy, 73100
        • Research Site
      • Roma, Italy, 00128
        • Research Site
      • Torino, Italy, 10100
        • Research Site
  • Spain
      • Madrid, Spain, 28041
        • Research Site
      • Madrid, Spain, 28009
        • Research Site
    • Andalucía
      • Sevilla, Andalucía, Spain, 41013
        • Research Site
    • Cataluña
      • Barcelona, Cataluña, Spain, 08003
        • Research Site
  • United Kingdom
      • Cardiff, United Kingdom, CF14 4XY
        • Research Site
      • London, United Kingdom, WC1X 8LD
        • Research Site
      • Sheffield, United Kingdom, S10 2SJ
        • Research Site
  • United States
    • California
      • Beverly Hills, California, United States, 90211
        • Research Site
      • Duarte, California, United States, 91010
        • Research Site
    • Colorado
      • Denver, Colorado, United States, 80019
        • Research Site
    • Connecticut
      • Farmington, Connecticut, United States, 06030
        • Research Site
      • Stratford, Connecticut, United States, 06615
        • Research Site
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Research Site
    • Florida
      • Gainesville, Florida, United States, 32611
        • Research Site
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Research Site
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Research Site
    • Iowa
      • Council Bluffs, Iowa, United States, 51503
        • Research Site
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Research Site
    • Nebraska
      • Omaha, Nebraska, United States, 68130
        • Research Site
      • Omaha, Nebraska, United States, 68105
        • Research Site
    • New York
      • Buffalo, New York, United States, 14215
        • Research Site
      • Buffalo, New York, United States, 14263
        • Research Site
      • Mineola, New York, United States, 11501
        • Research Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28232
        • Research Site
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Research Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Research Site
    • Tennessee
      • Memphis, Tennessee, United States, 38120
        • Research Site
      • Nashville, Tennessee, United States, 37232
        • Research Site
    • Texas
      • Houston, Texas, United States, 77030
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Subjects with cancer and ONJ

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Subjects with cancer and ONJ
Subjects with cancer and positively adjudicated ONJ

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Resolution rate and time to ONJ resolution
Time Frame: 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
5 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The clinical features of ONJ, including severity and staging at enrollment
Time Frame: 5 years
5 years
The frequency of risk factors for incident ONJ
Time Frame: 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
5 years
Therapeutic treatment patterns for ONJ
Time Frame: 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
5 years
Treatment patterns of antiresorptive agents subsequent to incident ONJ
Time Frame: 5 years
Characterize subsequent treatment patterns for ONJ including antimicrobial oral rinses, antibiotics, and surgery
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 16, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 16, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 22, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 16, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 21, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 18, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20101102

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

IPD Sharing Time Frame

Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.

IPD Sharing Access Criteria

Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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