Estimation of Off-Label Use of XGEVA® (Denosumab) Using Population-Based Databases in Denmark

This study aims to evaluate off-label XGEVA use in Denmark using data linked from registries and other sources in Northern Jutland Region and Copenhagen. This will allow for accurate assessment of prescriptions and diagnoses, especially those related to cancer patients during the first year post the initial market availability of XGEVA.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

XGEVA Off-label Use

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

The study will include patients with a prescription for XGEVA® given in secondary care with a minimum of 108 XGEVA users, in the Northern Jutland Region and Copenhagen during the first 1-year post XGEVA market availability, defined as 12 months after RADS opinion on 24th January 2013 or after the minimum sample has been achieved.

Exclusion criteria

n/a

Treatment and study plan

Database assessment of off-label XGEVA use

Drug

No intervention is planned during this study as it involves analyses of patient electronic records from Northern Jutland Region and Copenhagen

Primary outcomes

on or off label individual prescription type

Time frame: 12 months

Yes/no regarding whether an individual prescription was on (or off) label
on or off label patient treatment

Time frame: 12 months

Yes/no regarding whether the patient was treated on (or off) label

Secondary outcomes

type of off-label use

Time frame: 12 months

XGEVA prescription for each type of off-label use
off-label use stratified by administering department

Time frame: 12 months

Prescriptions that are for off-label use stratified by department that administers treatment

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Collaborators

University of Aarhus

Registry information

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2015
First posted: Feb 20, 2014
Registry last updated: May 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.