Osteonecrosis of the Jaw (ONJ) Case Registry

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

Study timelines

Date when funding contract was signed

Actual: 16/07/2010

Study start date

Actual: 01/10/2012

Data analysis start date

Planned: 08/02/2021

Actual: 08/02/2021

Date of interim report, if expected

Planned: 01/09/2014

Actual: 06/11/2014

Date of final study report

Planned: 29/09/2021

Actual: 13/01/2022

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Amgen

Study protocol

Initial protocol

20101102_Protocol_14Feb14

Updated protocol

20101102_01.02.06 Public Redacted Protocol Ver 1.0 2018-07-19 English

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable