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

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

Study timelines

Date when funding contract was signed

Actual: 13/05/2016

Study start date

Actual: 27/05/2010

Data analysis start date

Planned: 01/03/2022

Actual: 01/03/2022

Date of final study report

Planned: 02/08/2022

Actual: 23/08/2022

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Amgen

Study protocol

Initial protocol

20090601Protocol Amend 2 2016 Fully Redacted

Updated protocol

20090601Protocol Amend 2 2016-06-23

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable