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

May 27, 2015 updated by: Amgen
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

142

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population will include 108-200 patients who receive a prescription in secondary care of XGEVA during the first year after the initial market availability. These patients will be identified from the Danish National Registry of Patients and other sources in the Northern Jutland Region and Copenhagen.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cohort 1
Drug: Database assessment of off-label XGEVA use
No intervention is planned during this study as it involves analyses of patient electronic records from Northern Jutland Region and Copenhagen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
on or off label individual prescription type
Time Frame: 12 months
Yes/no regarding whether an individual prescription was on (or off) label
12 months
on or off label patient treatment
Time Frame: 12 months
Yes/no regarding whether the patient was treated on (or off) label
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
type of off-label use
Time Frame: 12 months
XGEVA prescription for each type of off-label use
12 months
off-label use stratified by administering department
Time Frame: 12 months
Prescriptions that are for off-label use stratified by department that administers treatment
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amgen

Collaborators

University of Aarhus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

February 13, 2014

First Submitted That Met QC Criteria

February 19, 2014

First Posted (Estimate)

February 20, 2014

Study Record Updates

Last Update Posted (Estimate)

May 29, 2015

Last Update Submitted That Met QC Criteria

May 27, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • 20101335

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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