Study identification

PURI

https://redirect.ema.europa.eu/resource/48699

EU PAS number

EUPAS17198

Study ID

48699

Official title and acronym

Prolia® Postmarketing Active Safety Surveillance Program for Soliciting Adverse Events of Special Interest in the United States (PASP-EMR Program)

DARWIN EU® study

No

Study countries

United States

Study description

To monitor the long-term safety of Prolia® (denosumab) and enhance the quality of data collection by proactively soliciting adverse event (AE) reporting of the 5 pre-specified AEs of special interest (AESI) from United States (US) health care providers (HCP e.g., physicians, licensed registered nurses, nurse practitioners, or physician assistants) of Prolia treated postmenopausal women and men with osteoporosis within the Postmarketing Active Safety Surveillance Program (PASP) Electronic Medical Record (EMR) (PASP-EMR program).

Study status

Finalised
Research institutions and networks

Institutions

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

Contact details

Akeem Yusuf

Primary lead investigator
Study timelines

Date when funding contract was signed

Actual:

Study start date

Actual:

Data analysis start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Amgen
Study protocol
Initial protocol
English (555.62 KB - PDF)View document
Updated protocol
English (2.84 MB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

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

Not applicable