Survey of Oncology Practitioners Prescribing XGEVA® in Europe to Evaluate Their Knowledge of XGEVA® Summary of Product Characteristics Pertaining to Osteonecrosis of the Jaw (20110102)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/11454
• EU PAS number:
  EUPAS5345
• Study ID:
  11454
• Official title and acronym:
  Survey of Oncology Practitioners Prescribing XGEVA® in Europe to Evaluate Their Knowledge of XGEVA® Summary of Product Characteristics Pertaining to Osteonecrosis of the Jaw (20110102)
• DARWIN EU® study:
  No
• Study countries:
  Denmark

  Finland

  France

  Germany

  Italy

  Norway

  Spain

  Sweden

  United Kingdom
• Study description:
  Osteonecrosis of the Jaw (ONJ) is an adverse effect of antiresorptive therapy that is well-recognized in patients with advanced cancer. Detailed information regarding this risk is specified in the Summary of Product Characteristics (SPC). The statements in the SPC are the most important mechanism for minimizing the risk for ONJ. The study objective is to measure the knowledge of oncology practitioners prescribing XGEVA® regarding the content pertaining to ONJ in the SPC after commercial availability.
• Study status:
  Finalised

Research institutions and networks

Institutions

Amgen

United States

Study timelines

Date when funding contract was signed

Actual: 13/07/2012

Study start date

Actual: 08/08/2012

Data analysis start date

Planned: 14/08/2014

Actual: 12/06/2014

Date of interim report, if expected

Planned: 05/09/2014

Actual: 13/11/2014

Date of final study report

Planned: 03/09/2015

Actual: 23/09/2015

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Amgen

Study protocol

Initial protocol

XGEVA_20110102_Protocol_11Feb14

Regulatory

• Was the study required by a regulatory body?:
  No