Study identification

PURI

https://redirect.ema.europa.eu/resource/45163

EU PAS number

EUPAS5605

Study ID

45163

Official title and acronym

Osteonecrosis of the Jaw (ONJ) Case Registry

DARWIN EU® study

No

Study countries

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

Study 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.

Study status

Finalised
Research institutions and networks

Institutions

Amgen
United States
First published:
21/02/2024
Institution

Contact details

Global Development Leader Amgen, Inc

Primary lead investigator
Study timelines

Date when funding contract was signed

Actual:

Study start date

Actual:

Data analysis start date

Planned:
Actual:

Date of interim report, if expected

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Amgen
Study protocol
Initial protocol
English (728.09 KB - PDF)View document
Updated protocol
English (1.1 MB - PDF)View document
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable