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

Completed

• Conditions: Solid Tumours; Bone Metastasis
• Interventions: Other: Physician Survey

• Registration Number: NCT01998607
• Lead Sponsor: Amgen

Brief Summary

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.

Detailed Description

This is a multiple cross-sectional survey study of practicing oncology practitioners prescribing XGEVA in Europe from across but not limited to the 5 largest European countries by population (including France, Germany, Italy, Spain and the U.K.) and 4 Nordic countries (Denmark, Finland, Norway and Sweden). The survey will be conducted in two rounds. The two survey rounds will be conducted 12 to 18 months and 24 to 30 months after XGEVA becomes commercially available in the participating countries. The initial contact and screening of potential participating oncology practitioners will continue until a total of 210 eligible and consenting oncology practitioners complete the survey per round. For the 5 largest European countries by population, it is intended that 30 oncology practitioners will be surveyed per country per survey round. If this sample size cannot be achieved, oncology practitioners from another country in that region will be surveyed to achieve a regional sample size of 150 per survey round. Oncology practitioners from the Nordic countries will be surveyed to achieve a regional sample size of 60 per survey round. For all countires, the number of surveys collected in each country in the second survey round will, where possible, equate to the number of surveys collected in each country in the first survey round.

Study Timeline

• Study Start: 2013-02-04
• Study First Submitted: 2013-11-25
• Study First Submitted QC: 2013-11-25
• Study First Posted: 2013-12-02
• Primary Completion: 2015-05-15
• Study Completion: 2015-05-15
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-05
• Last Update Posted: 2018-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 420

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Round 1	Physician Survey	Survey of 210 oncologists 12 - 18 months after commercial availability of XGEVA® in the respective country
Round 2	Physician Survey	Survey of 210 oncologists 24 - 30 months after commercial availability of XGEVA® in the respective country

Primary Outcome Measures

Name	Time	Method
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)	12 and 24 months after commercial availability of XGEVA® in the respective country