NCT02066805

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
142

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2014

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

January 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 13, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 20, 2014

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

May 29, 2015

Status Verified

May 1, 2015

Enrollment Period

1.1 years

First QC Date

February 13, 2014

Last Update Submit

May 27, 2015

Conditions

XGEVA Off-label Use

Outcome Measures

Primary Outcomes (2)

  • on or off label individual prescription type

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

    12 months

  • on or off label patient treatment

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

    12 months

Secondary Outcomes (2)

  • type of off-label use

    12 months

  • off-label use stratified by administering department

    12 months

Study Arms (1)

Cohort 1

Drug: Database assessment of off-label XGEVA use

Interventions

Database assessment of off-label XGEVA useDRUG

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

Cohort 1

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • n/a

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

Study Officials

  • MD

    Amgen

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2014

First Posted

February 20, 2014

Study Start

January 1, 2014

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

May 29, 2015

Record last verified: 2015-05