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NCT01998607 Clinical Trial

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

Solid Tumours Clinical Trial

Official title:
Survey of Oncology Practitioners Prescribing XGEVA® in Europe to Evaluate Their Knowledge of XGEVA® Summary of Product Characteristics Pertaining to Osteonecrosis of the Jaw

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01998607
Other study ID # 20110102
Secondary ID
Status Completed
Phase N/A
First received November 25, 2013
Last updated January 5, 2018
Start date February 4, 2013
Est. completion date May 15, 2015

Study information
Verified date January 2018
Source Amgen
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 420
Est. completion date May 15, 2015
Est. primary completion date May 15, 2015
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Practicing oncology specialists who have treated at least 5 adult patients with bone metastases from solid tumours in the last quarter. Must have prescribed XGEVA® within the last 12 months. Must not have participated in a previous survey round

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Physician Survey
Eligible physicians will be contacted to perform the physician survey. A standardised online questionnaire will be used to collect information about the physician's awareness of the Summary of Product characteristics (SPC) pertaining to osteonecrosis of the jaw (ONJ) in the last 6-18 months.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Amgen

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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