Osteonecrosis of the Jaw (ONJ) Case Registry

NCT01666106 | Completed

• 1 other identifier: 20101102
• Study Type: observational
• Target: 327
• Locations: 11 countries
• Sites: 64

Brief Summary

Osteonecrosis of the Jaw (ONJ) Case Registry

Conditions

Osteonecrosis of the Jaw

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• The clinical features of ONJ, including severity and staging at enrollment

  5 years

• The frequency of risk factors for incident ONJ

  5 years

• Therapeutic treatment patterns for ONJ

  5 years

• Treatment patterns of antiresorptive agents subsequent to incident ONJ

  5 years

Study Arms (1)

Subjects with cancer and ONJ

Subjects with cancer and positively adjudicated ONJ

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subjects with cancer and ONJ

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Amgen: lead

Study Sites (64)

Research Site

Beverly Hills, California, 90211, United States

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Duarte, California, 91010, United States

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Denver, Colorado, 80019, United States

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Farmington, Connecticut, 06030, United States

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Stratford, Connecticut, 06615, United States

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Washington D.C., District of Columbia, 20010, United States

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Gainesville, Florida, 32611, United States

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Atlanta, Georgia, 30322, United States

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Chicago, Illinois, 60612, United States

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Council Bluffs, Iowa, 51503, United States

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Baltimore, Maryland, 21201, United States

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Omaha, Nebraska, 68105, United States

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Omaha, Nebraska, 68130, United States

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Buffalo, New York, 14215, United States

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Buffalo, New York, 14263, United States

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Mineola, New York, 11501, United States

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Charlotte, North Carolina, 28232, United States

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Cleveland, Ohio, 44106, United States

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Philadelphia, Pennsylvania, 19104, United States

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Memphis, Tennessee, 38120, United States

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Nashville, Tennessee, 37232, United States

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Houston, Texas, 77030, United States

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Brussels, 1000, Belgium

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Edegem, 2650, Belgium

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Leuven, 3000, Belgium

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Halifax, Nova Scotia, B3H 2Y4, Canada

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Greater Sudbury, Ontario, P3E 5J1, Canada

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Kitchener, Ontario, N2N 2B9, Canada

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Sault Ste. Marie, Ontario, P6B 0A8, Canada

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Québec, Quebec, G1S 4L8, Canada

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Aarhus C, 8000, Denmark

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København Ø, 2100, Denmark

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Helsinki, 00029, Finland

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Kuopio, 70211, Finland

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Oulu, 90029, Finland

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Bordeaux, 33075, France

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Brest, 29609, France

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Lyon, 69008, France

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Paris, 75651, France

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Saint-Herblain, 44800, France

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Berlin, 12200, Germany

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Berlin, 13055, Germany

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Cologne, 50677, Germany

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Düsseldorf, 40225, Germany

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Mühlhausen, 99974, Germany

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München, 80335, Germany

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München, 80337, Germany

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Regensburg, 93053, Germany

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Athens, 11527, Greece

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Athens, 11528, Greece

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Thessaloniki, 54121, Greece

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Thessaloniki, 57010, Greece

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Alessandria, 15121, Italy

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Brescia, 25123, Italy

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Lecce, 73100, Italy

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Roma, 00128, Italy

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Torino, 10100, Italy

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Seville, Andalusia, 41013, Spain

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Barcelona, Catalonia, 08003, Spain

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Madrid, 28009, Spain

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Madrid, 28041, Spain

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Cardiff, CF14 4XY, United Kingdom

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London, WC1X 8LD, United Kingdom

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Sheffield, S10 2SJ, United Kingdom

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Related Publications (1)

• 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.

  PMID: 29275525 BACKGROUND

Related Links

• AmgenTrials clinical trials website

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2012
• First Posted: August 16, 2012
• Study Start: October 1, 2012
• Primary Completion: December 16, 2020
• Study Completion: December 16, 2020
• Last Updated: December 21, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• 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.
• 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.

Locations

IT (5); ES (4); FI (3); US (22); GB (3); CA (5); GR (4); FR (5); DK (2); BE (3); DE (8)