Status: Ongoing First registered on: 27/01/2015
Last updated on: 13/12/2018
1. Study identification
EU PAS Register NumberEUPAS8463
Official titleEstudio de casos y controles sobre el riesgo de fractura atípica de fémur asociada al uso de bifosfonatos
Study title acronym
Study typeObservational study
Brief description of the studyObjectives: to evaluate the association between bisphosphonate use and the risk of atypical femoral fractures among women aged 50 or older. Desing: case-control study. Main outcome measures: Cases were defined as women aged 50 years or older with diagnosis of subtrochanteric or diaphyseal fracture, recorded in the Data Warehouse Southern Metropolitan Management Administration Area of the ICS between 1 April 2010 and 31 December 2014, and with at least 1 year of follow-up before the index date. Four each case, for age-matched and primary healthcare facility-matched controls were selected from the database. Statistical analysis: OR for atypical femoral fracture risk associated to the use of bisphosphonates will be determined by logistic regression. Model will be adjusted for comorbidities and use of other drugs.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)? Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsClinical Pharmacology Service, HUB/IDIBELL
Department/Research groupClinical Pharmacology Service
Organisation/affiliationBellvitge University Hospital/IDIBELL
Website/Homepagewww.bellvitgehospital.cat
Details of (Primary) lead investigator
Title Dr
Last name Pedrós
First name Consuelo
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
National study

Spain
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed27/01/2015
Start date of data collection02/03/201502/03/2015
Start date of data analysis01/01/2019
Date of interim report, if expected
Date of final study report31/12/2019
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
Charities
Government body
Research councils
EU funding scheme
OtherNo specific funding100
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Pedrós
First name Consuelo
Address line 1Servicio de Farmacología Clínica
Address line 2Hospital Universitario de Bellvitge 
Address line 3c/Feixa Llarga s/n 
CityL’Hospitalet de Llobregat 
Postcode08907 
CountrySpain
Phone number (incl. country code)34-932607220 
Alternative phone number34-932607279 
Fax number (incl. country code)34-932607223 
Email address cpedros@bellvitgehospital.cat
Public Enquiries
Title Dr 
Last name Pedrós 
First name Consuelo 
Address line 1Servicio de Farmacología Clínica 
Address line 2Hospital Universitario de Bellvitge 
Address line 3c/Feixa Llarga s/n 
CityL’Hospitalet de Llobregat 
Postcode08907 
CountrySpain 
Phone number (incl. country code)34-932607220 
Alternative phone number34-932607279 
Fax number (incl. country code)34-932607223 
Email address cpedros@bellvitgehospital.cat 
Top