Osteonecrosis of the Jaw (ONJ) Case Registry

Osteonecrosis of the Jaw (ONJ) Case Registry

Study Overview

• Status: Completed
• Conditions: Osteonecrosis of the Jaw

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: Observational
• Enrollment (Actual): 327

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Subjects with cancer and ONJ; Subjects with cancer and positively adjudicated ONJ

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Resolution rate and time to ONJ resolution	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

Outcome Measure	Measure Description	Time Frame
The clinical features of ONJ, including severity and staging at enrollment		5 years
The frequency of risk factors for incident ONJ	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	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	Characterize subsequent treatment patterns for ONJ including antimicrobial oral rinses, antibiotics, and surgery	5 years

Collaborators and Investigators

• Sponsor: Amgen

Publications and helpful links

General Publications

• Schiodt M, Vadhan-Raj S, Chambers MS, Nicolatou-Galitis O, Politis C, Coropciuc R, Fedele S, Jandial D, Zhang J, Ma H, Saunders DP. A multicenter case registry study on medication-related osteonecrosis of the jaw in patients with advanced cancer. Support Care Cancer. 2018 Jun;26(6):1905-1915. doi: 10.1007/s00520-017-4003-2. Epub 2017 Dec 23.

Helpful Links

• AmgenTrials clinical trials website

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2012
• Primary Completion (Actual): December 16, 2020
• Study Completion (Actual): December 16, 2020

Study Registration Dates

• First Submitted: June 22, 2012
• First Submitted That Met QC Criteria: August 14, 2012
• First Posted (Estimate): August 16, 2012

Study Record Updates

• Last Update Posted (Actual): December 21, 2020
• Last Update Submitted That Met QC Criteria: December 18, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Musculoskeletal Diseases; Bone Diseases; Osteonecrosis
• Other Study ID 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)