Use of benzodiazepines and risk of hip/femur fracture. A methodological comparison across data sources and epidemiological design.

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/6179
• EU PAS number:
  EUPAS2385
• Study ID:
  6179
• Official title and acronym:
  Use of benzodiazepines and risk of hip/femur fracture. A methodological comparison across data sources and epidemiological design.
• DARWIN EU® study:
  No
• Study countries:
  Denmark

  Germany

  Netherlands

  Spain

  United Kingdom
• Study description:
  The studies described in this protocol are all performed within the framework of PROTECT (Pharmacoepidemiological Research on Outcomes of Therapeutics by a European ConsorTium) Work Package 2 and Working Group 1. The primary aim of these studies is to develop, test and disseminate methodological standards for the design, conduct and analysis of Pharmacoepidemiological (PE) studies applicable to different safety issues and using different data sources. To achieve this, results from PE studies on 5 key Drug / adverse events (D-AEs) pairs performed in different databases will be evaluated. The use of benzodiazepines associated to the risk of hip/femur fracture is one of the D-AEs pairs of interest. Therefore, emphasis will be on the methodological aspects of the studies in this protocol and not on the clinical consequences of studying the association under investigation.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Agencia Española de Medicamentos y Productos Sanitarios (Spanish Agency for Medicines and Medical Devices, AEMPS)

Spain

Division of Pharmacoepidemiology & Clinical Pharmacology (PECP), Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University

Netherlands

Agencia Española de Medicamentos y Productos Sanitarios (Spanish Agency for Medicines and Medical Devices, AEMPS)

Spain

European Medicines Agency (EMA)

Ludwig-Maximilians-University Munich

Merck & Co.

GlaxoSmithKline (GSK)

Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) Spain, European Medicines Agency United Kingdom, Lægemiddelstyrelsen (Danish Medicines Agency) (DKMA) Denmark, Ludwig-Maximilians-Universität-München (LMU MUENCHEN) Germany, MerckSerono Switzerland, Glaxo Smith Kline United Kingdom

Networks

PROTECT

Belgium

Denmark

France

Germany

Italy

Netherlands

Poland

Spain

Sweden

Switzerland

United Kingdom

Study timelines

Date when funding contract was signed

Planned: 19/08/2009

Actual: 19/08/2009

Study start date

Planned: 03/10/2011

Actual: 03/10/2011

Date of final study report

Planned: 01/02/2014

Sources of funding

Pharmaceutical company and other private sector 

EU institutional research programme

More details on funding

Amgen, AstraZeneca, Genzyme, GlaxoSmithKline, MerckSerono, Novartis, Roche, Pfizer, Innovative Medicines Initiative (IMI)

Study protocol

Initial protocol

PROTECT_Final Protocol_ BenzoHIPfracture_14Nov2011Amend1_approved29Feb2012

Updated protocol

PROTECT_WP2 Final Protocol_ BenzoHIPfracture_14Nov2011_Amend4_Dec2013

Regulatory

• Was the study required by a regulatory body?:
  No