NCT01666106|Completed
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Sponsor study identifier
observational
327
11 countries
64
Study Start
October 1, 2012
Actual (reported)Primary Completion
December 16, 2020
Actual (reported)Study Completion
December 16, 2020
Actual (reported)Osteonecrosis of the Jaw (ONJ) Case Registry
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 16, 2020
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 22, 2012
Actual (reported)August 16, 2012
Actual (reported)October 1, 2012
Actual (reported)December 16, 2020
Actual (reported)December 16, 2020
Actual (reported)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
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
Subjects with cancer and positively adjudicated ONJ
Subjects with cancer and ONJ
Research Site
Beverly Hills, California, 90211, United States
Research Site
Duarte, California, 91010, United States
Research Site
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
Research Site
Gainesville, Florida, 32611, United States
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.
MD
Amgen
327 participants (actual enrollment reported by the registry).
First Submitted
June 22, 2012
First Posted
August 16, 2012
Study Start
October 1, 2012
Actual (reported)Osteonecrosis of the Jaw (ONJ) and Infection Among Nordic Cancer Patients Treated With XGEVA™ or Zoledronic Acid
Contact the study team to confirm eligibility.
Research Site
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
Research Site
Sheffield, S10 2SJ, United Kingdom
Primary Completion
December 16, 2020
Actual (reported)Study Completion
December 16, 2020
Actual (reported)Last Updated
December 21, 2020
Record last verified: 2020-12
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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