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

Amgen

Status: Completed

Conditions: XGEVA Off-label Use

Treatments: Drug: Database assessment of off-label XGEVA use

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02066805

20101335

Details and patient eligibility

About

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.

Enrollment: 142 patients

Sex

Volunteers: No Healthy Volunteers

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

Trial design

142 participants in 1 patient group

Cohort 1

Treatment:

Drug: Database assessment of off-label XGEVA use