Survey of XGEVA® presrcibers in Europe to Evaluate Their Knowledge of the Summary of Product Characteristics Pertaining to Osteonecrosis of the Jaw

Sponsor ID

20110102

Clinicaltrials.gov ID

NCT01998607

EUCTIS ID

N/A

EudraCT ID

N/A

Study Details

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.

Additional Study Details

Phase

N/A

Product

denosumab

Type

Observational

Masking

N/A

Enrollment

420

Additional Study Details

Protocol Summary

Primary Outcome Measures

Proportion of participating oncology practitioners prescribing XGEVA® who are aware of the SPC statements pertaining to ONJ (each question pertaining to a SPC statement will be assessed seperately at the end of each survey round)

Timeframe: 12 and 24 months after commercial availability of XGEVA® in the respective country

Secondary Outcome Measures

Not Available

Study Documents

Study Synopsis

Available Language(s): English

Download Document(s)

Locations

No locations found.