Clinical trial NCT01666106: Osteonecrosis of the Jaw (ONJ) Case Registry
Official title: Osteonecrosis of the Jaw (ONJ) Case Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteonecrosis of the Jaw
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2012-08-16
Enrollment: 327
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects with cancer and ONJ

Brief summary: Osteonecrosis of the Jaw (ONJ) Case Registry

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Resolution rate and time to ONJ resolution
timeFrame: 5 years
Secondary outcomes:
measure: The clinical features of ONJ, including severity and staging at enrollment
timeFrame: 5 years
measure: The frequency of risk factors for incident ONJ
timeFrame: 5 years
measure: Therapeutic treatment patterns for ONJ
timeFrame: 5 years
measure: Treatment patterns of antiresorptive agents subsequent to incident ONJ
timeFrame: 5 years
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Research Site
state: California
city: Duarte
country: United States
facility: Research Site
state: California
city: Denver
country: United States
facility: Research Site
state: Colorado
city: Farmington
country: United States
facility: Research Site
state: Connecticut
city: Stratford
country: United States
facility: Research Site
state: Connecticut
city: Washington
country: United States
facility: Research Site
state: District of Columbia
city: Gainesville
country: United States
facility: Research Site
state: Florida
city: Atlanta
country: United States
facility: Research Site
state: Georgia
city: Chicago
country: United States
facility: Research Site
state: Illinois
city: Council Bluffs
country: United States
facility: Research Site
state: Iowa
city: Baltimore
country: United States
facility: Research Site
state: Maryland
city: Omaha
country: United States
facility: Research Site
state: Nebraska
city: Omaha
country: United States
facility: Research Site
state: Nebraska
city: Buffalo
country: United States
facility: Research Site
state: New York
city: Buffalo
country: United States
facility: Research Site
state: New York
city: Mineola
country: United States
facility: Research Site
state: New York
city: Charlotte
country: United States
facility: Research Site
state: North Carolina
city: Cleveland
country: United States
facility: Research Site
state: Ohio
city: Philadelphia
country: United States
facility: Research Site
state: Pennsylvania
city: Memphis
country: United States
facility: Research Site
state: Tennessee
city: Nashville
country: United States
facility: Research Site
state: Tennessee
city: Houston
country: United States
facility: Research Site
state: Texas
city: Bruxelles
country: Belgium
facility: Research Site
city: Edegem
country: Belgium
facility: Research Site
city: Leuven
country: Belgium
facility: Research Site
city: Halifax
country: Canada
facility: Research Site
state: Nova Scotia
city: Kitchener
country: Canada
facility: Research Site
state: Ontario
city: Sault Ste. Marie
country: Canada
facility: Research Site
state: Ontario
city: Sudbury
country: Canada
facility: Research Site
state: Ontario
city: Québec
country: Canada
facility: Research Site
state: Quebec
city: Aarhus C
country: Denmark
facility: Research Site
city: Kobenhavn O
country: Denmark
facility: Research Site
city: Helsinki
country: Finland
facility: Research Site
city: Kuopio
country: Finland
facility: Research Site
city: Oulu
country: Finland
facility: Research Site
city: Bordeaux
country: France
facility: Research Site
city: Brest Cedex 2
country: France
facility: Research Site
city: Lyon
country: France
facility: Research Site
city: Paris Cedex 13
country: France
facility: Research Site
city: Saint Herblain
country: France
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Düsseldorf
country: Germany
facility: Research Site
city: Köln
country: Germany
facility: Research Site
city: Mühlhausen
country: Germany
facility: Research Site
city: München
country: Germany
facility: Research Site
city: München
country: Germany
facility: Research Site
city: Regensburg
country: Germany
facility: Research Site
city: Athens
country: Greece
facility: Research Site
city: Athens
country: Greece
facility: Research Site
city: Thessaloniki
country: Greece
facility: Research Site
city: Thessaloniki
country: Greece
facility: Research Site
city: Alessandria
country: Italy
facility: Research Site
city: Brescia
country: Italy
facility: Research Site
city: Lecce
country: Italy
facility: Research Site
city: Roma
country: Italy
facility: Research Site
city: Torino
country: Italy
facility: Research Site
city: Sevilla
country: Spain
facility: Research Site
state: Andalucía
city: Barcelona
country: Spain
facility: Research Site
state: Cataluña
city: Madrid
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Cardiff
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: Sheffield
country: United Kingdom
facility: Research Site
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: 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.