Estudio de casos y controles sobre el riesgo de fractura atípica de fémur asociada al uso de bifosfonatos

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/26997
• EU PAS number:
  EUPAS8463
• Study ID:
  26997
• Official title and acronym:
  Estudio de casos y controles sobre el riesgo de fractura atípica de fémur asociada al uso de bifosfonatos
• DARWIN EU® study:
  No
• Study countries:
  Spain
• Study description:
  Objectives: 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.
• Study status:
  Ongoing

Research institution and networks

Institutions

Bellvitge University Hospital

IDIBELL

Study timelines

Date when funding contract was signed

Planned: 27/01/2015

Study start date

Planned: 02/03/2015

Actual: 02/03/2015

Data analysis start date

Planned: 01/01/2019

Date of final study report

Planned: 31/12/2019

Sources of funding

Other

More details on funding

No specific funding

Study protocol

Initial protocol

Protocolo T13 VAL-SI V1 27-01-15

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable