Study identification

PURI

https://redirect.ema.europa.eu/resource/20749

EU PAS number

EUPAS2616

Study ID

20749

Official title and acronym

Risk of cardiac valve disorders associated with the use of biphosphonates (Cardiac valve disorders and biphosphonate use)

DARWIN EU® study

No

Study countries

Italy
Netherlands
United Kingdom

Study description

A signal of disproportionate reporting concerning the risk of cardiac valve calcification leading to cardiac valve insufficiency associated with the use of bisphosphonates was found in EudraVigilance. A similar association between bisphosphonate use and valvular and vascular calcification in women has also been previously described in a cohort study conducted in the United States (MESA study).The primary objective of this signal strengthening study is to confirm or refute the presence of a possible risk of cardiac valve disorders (all types of disorders, confirmed by cardiac imaging) in patients treated with bisphosphonates using EU longitudinal healthcare data from the EU-ADR Alliance. This signal strengthening study will determine the need for, and feasibility of conducting a traditional hypothesis testing study.Signal strengthening will be performed using the most recently updated demographic, clinical, and prescription data from six databases in three EU member states (Italy, Netherlands, the United Kingdom), pooled using a distributed network approach by generation of common input data followed by local aggregation through custom-built software, Jerboa©. Potential cases of cardiac valve disorders in the database network will be identified using database-specific coding algorithms. Exposure to bisphosphonates will be assessed with drug prescription/dispensing data using the World Health Organisation’s (WHO) Anatomical Therapeutic Chemical (ATC) classification system. Several signal detection/strengthening methods will be employed to assess the association of cardiac valve disorder and use of bisphosphonates

Study status

Finalised
Research institutions and networks

Institutions

Primary Care Research Institute Jordi Gol

Networks

Contact details

Miriam Sturkenboom

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:
Actual:

Date of interim report, if expected

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
EMA
Study protocol
Initial protocol

D1.b. Final Protocol signal strengthening (BI)_23May2012

English (1.23 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