Study identification

PURI

https://redirect.ema.europa.eu/resource/1000000393

EU PAS number

EUPAS1000000393

Study ID

1000000393

Official title and acronym

Periodic Knowledge, Attitudes, and Behavior (KAB) Survey of Certified Prescribers to Assess Understanding of the Risks with the Prolia Risk Evaluation and Mitigation of Strategy (REMS) (20240121)

DARWIN EU® study

No

Study countries

United States

Study description

This study will be conducted to survey HCPs who are currently prescribing and those who have the potential to prescribe Prolia, who are part of the REMS Communication Plan outreach, and who have not been debarred or sanctioned in order to assess their awareness and understanding of the risk of severe hypocalcemia with Prolia, the Prolia REMS requirements, and the REMS goals and materials.

Study status

Planned
Research institutions and networks

Institutions

Amgen
United States
First published:
21/02/2024
Institution

Contact details

Global Development Leader Amgen Inc.

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:

Data analysis start date

Planned:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 
Study protocol
Initial protocol

Protocol-Published Original denosumab 20240121.pdf

English (1.8 MB - PDF)View document
Updated protocol

Protocol-Published Amendment denosumab 20240121 1.pdf

English (2.37 MB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

Non-EU RMP only