Back to Search Results
Study Complete
Sponsor ID
20101102

Osteonecrosis of the Jaw (ONJ) Case Registry

Sponsor ID
20101102
Clinicaltrials.gov ID
NCT01666106
EUCTIS ID
N/A
EudraCT ID
N/A
Contact Us

Study Details

Osteonecrosis of the Jaw (ONJ) Case Registry

Additional Study Details

Phase
N/A
Product
denosumab
Type
Observational
Masking
N/A
Enrollment
327
Additional Study Details

Protocol Summary

Primary Outcome Measures

Resolution rate and time to ONJ resolution

Timeframe: 5 years

Secondary Outcome Measures

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

Timeframe: 5 years

The frequency of risk factors for incident ONJ

Timeframe: 5 years

Therapeutic treatment patterns for ONJ

Timeframe: 5 years

Treatment patterns of antiresorptive agents subsequent to incident ONJ

Timeframe: 5 years

Locations

Location
Status
Contact Us
Location
Research Site
Kitchener, ON, Canada, N2N 2B9
Status
Completed
Location
Research Site
Mineola, NY, United States, 11501
Status
Completed
Location
Research Site
Buffalo, NY, United States, 14263
Status
Recruiting
Location
Research Site
Duarte, CA, United States, 91010
Status
Completed
Location
Research Site
Houston, TX, United States, 77030
Status
Recruiting
Location
Research Site
Council Bluffs, IA, United States, 51503
Status
Completed
Showing {first} - {last} of {total} Results
Study Info
Age
18+ years
Condition
  • Osteonecrosis
    • Sex
    All
    Trial Dates
    Oct 2012 - Dec 2020
    Inclusion and Exclusion 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.