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

NCT ID: NCT02066805

Last Updated: 2015-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

142 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-31

Study Completion Date

2015-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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XGEVA Off-label Use

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Cohort 1

Database assessment of off-label XGEVA use

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Eligibility Criteria

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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
Eligible Sex

Accepts Healthy Volunteers

No

Sponsors

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University of Aarhus

OTHER

Sponsor Role collaborator

Amgen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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MD

Role: STUDY_DIRECTOR

Amgen

Related Links

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http://www.amgentrials.com

AmgenTrials clinical trials website

Other Identifiers

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20101335

Identifier Type: -

Identifier Source: org_study_id