NCT01998607

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
420

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2013

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 4, 2013

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 25, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 2, 2013

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2015

Completed
Last Updated

January 9, 2018

Status Verified

January 1, 2018

Enrollment Period

2.3 years

First QC Date

November 25, 2013

Last Update Submit

January 5, 2018

Conditions

Solid TumoursBone Metastasis

Keywords

Solid tumoursBone Metastasis

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Round 1

Survey of 210 oncologists 12 - 18 months after commercial availability of XGEVA® in the respective country

Other: Physician Survey

Round 2

Survey of 210 oncologists 24 - 30 months after commercial availability of XGEVA® in the respective country

Other: Physician Survey

Interventions

Physician SurveyOTHER

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.

Also known as: This is an observational study.
Round 1Round 2

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Oncology specialists treating adult patients with bone metastases from solid tumours

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Links

Study Officials

  • MD

    Amgen

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 25, 2013

First Posted

December 2, 2013

Study Start

February 4, 2013

Primary Completion

May 15, 2015

Study Completion

May 15, 2015

Last Updated

January 9, 2018

Record last verified: 2018-01