Study identification

EU PAS number

EUPAS21542

Study ID

22265

Official title and acronym

Prospective Observational Non-interventional Study to Describe Characteristics and Management of Patients With Giant Cell Tumor of Bone Treated With XGEVA and Its Use in Routine Clinical Practice in France (20150360)

DARWIN EU® study

No

Study countries

France

Study description

The French Health Authorities requested, in July 2015, a study with the objective to « provide long-term data on patients with giant cell tumor of bone treated with XGEVA”.
This study should be able to provide real world data on the characteristics of treated patients, the conditions of use of XGEVA, the XGEVA impact on morbidity and the Health related quality of life of the patients.
This study is a prospective observational study.

Study status

Ongoing
Research institutions and networks

Institutions

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

Networks

ReSos, National network specialized in pathology and care of bone sarcomas

Contact details

Global Development Leader Amgen Inc.

Primary lead investigator

Study timelines

Date when funding contract was signed

Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:
Actual:

Date of interim report, if expected

Planned:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Amgen
Regulatory

Was the study required by a regulatory body?

Yes

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

Not applicable