Osteonecrosis of the Jaw (ONJ) Case Registry

Osteonecrosis of the Jaw Clinical Trial

Official title:

Osteonecrosis of the Jaw (ONJ) Case Registry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01666106
• Other study ID #: 20101102
• Status: Completed
• Start date: October 1, 2012
• Est. completion date: December 16, 2020

Study information

• Verified date: December 2020
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Osteonecrosis of the Jaw (ONJ) Case Registry

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Osteonecrosis
• Osteonecrosis of the Jaw

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  Denmark,  Finland,  France,  Germany,  Greece,  Italy,  Spain,  United Kingdom, 

References & 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. — View Citation

Outcome

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

External Links

•   AmgenTrials clinical trials website