European non-interventional post-authorization safety study (PASS) to evaluate cardiovascular (CV) events and all-cause mortality in patients newly exposed to abaloparatide or teriparatide

Study identification

• EU PAS number:
  EUPAS1000000613
• Study ID:
  1000000613
• Official title and acronym:
  European non-interventional post-authorization safety study (PASS) to evaluate cardiovascular (CV) events and all-cause mortality in patients newly exposed to abaloparatide or teriparatide
• DARWIN EU® study:
  No
• Study countries:
  France

  Germany

  Italy

  Spain
• Study description:
  Research question: Is the risk of major cardiovascular events (MACE-1 and MACE-2), arrhythmia, and all-cause mortality (including CV death) associated with abaloparatide use in routine clinical practice in Europe not different relative to teriparatide?
• Study status:
  Planned

Research institutions and networks

Institutions

Pharmaco- and Device epidemiology, University of Oxford

United Kingdom

Theramex Ireland Ltd

Study timelines

Date when funding contract was signed

Actual:19/03/2025

Study start date

Planned:01/04/2025

Date of interim report, if expected

Planned:31/12/2026

Date of final study report

Planned:31/03/2028

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

The study is sponsored by Theramex Ireland Limited.

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)