Osteonecrosis of the Jaw Clinical Trial
Official title:
Osteonecrosis of the Jaw (ONJ) Case Registry
NCT number | NCT01666106 |
Other study ID # | 20101102 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | October 1, 2012 |
Est. completion date | December 16, 2020 |
Verified date | December 2020 |
Source | Amgen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Osteonecrosis of the Jaw (ONJ) Case Registry
Status | Completed |
Enrollment | 327 |
Est. completion date | December 16, 2020 |
Est. primary completion date | December 16, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Belgium | Research Site | Bruxelles | |
Belgium | Research Site | Edegem | |
Belgium | Research Site | Leuven | |
Canada | Research Site | Halifax | Nova Scotia |
Canada | Research Site | Kitchener | Ontario |
Canada | Research Site | Québec | Quebec |
Canada | Research Site | Sault Ste. Marie | Ontario |
Canada | Research Site | Sudbury | Ontario |
Denmark | Research Site | Aarhus C | |
Denmark | Research Site | Kobenhavn O | |
Finland | Research Site | Helsinki | |
Finland | Research Site | Kuopio | |
Finland | Research Site | Oulu | |
France | Research Site | Bordeaux | |
France | Research Site | Brest Cedex 2 | |
France | Research Site | Lyon | |
France | Research Site | Paris Cedex 13 | |
France | Research Site | Saint Herblain | |
Germany | Research Site | Berlin | |
Germany | Research Site | Berlin | |
Germany | Research Site | Düsseldorf | |
Germany | Research Site | Köln | |
Germany | Research Site | Mühlhausen | |
Germany | Research Site | München | |
Germany | Research Site | München | |
Germany | Research Site | Regensburg | |
Greece | Research Site | Athens | |
Greece | Research Site | Athens | |
Greece | Research Site | Thessaloniki | |
Greece | Research Site | Thessaloniki | |
Italy | Research Site | Alessandria | |
Italy | Research Site | Brescia | |
Italy | Research Site | Lecce | |
Italy | Research Site | Roma | |
Italy | Research Site | Torino | |
Spain | Research Site | Barcelona | Cataluña |
Spain | Research Site | Madrid | |
Spain | Research Site | Madrid | |
Spain | Research Site | Sevilla | Andalucía |
United Kingdom | Research Site | Cardiff | |
United Kingdom | Research Site | London | |
United Kingdom | Research Site | Sheffield | |
United States | Research Site | Atlanta | Georgia |
United States | Research Site | Baltimore | Maryland |
United States | Research Site | Beverly Hills | California |
United States | Research Site | Buffalo | New York |
United States | Research Site | Buffalo | New York |
United States | Research Site | Charlotte | North Carolina |
United States | Research Site | Chicago | Illinois |
United States | Research Site | Cleveland | Ohio |
United States | Research Site | Council Bluffs | Iowa |
United States | Research Site | Denver | Colorado |
United States | Research Site | Duarte | California |
United States | Research Site | Farmington | Connecticut |
United States | Research Site | Gainesville | Florida |
United States | Research Site | Houston | Texas |
United States | Research Site | Memphis | Tennessee |
United States | Research Site | Mineola | New York |
United States | Research Site | Nashville | Tennessee |
United States | Research Site | Omaha | Nebraska |
United States | Research Site | Omaha | Nebraska |
United States | Research Site | Philadelphia | Pennsylvania |
United States | Research Site | Stratford | Connecticut |
United States | Research Site | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
Amgen |
United States, Belgium, Canada, Denmark, Finland, France, Germany, Greece, Italy, Spain, United Kingdom,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | The clinical features of ONJ, including severity and staging at enrollment | 5 years | ||
Secondary | 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 | |
Secondary | 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 | |
Secondary | Treatment patterns of antiresorptive agents subsequent to incident ONJ | Characterize subsequent treatment patterns for ONJ including antimicrobial oral rinses, antibiotics, and surgery | 5 years |
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