Multinational Observational Database Study on Imminent Osteoporotic Fracture Risk: Stage 1 (IFRISK)

Study identification

• EU PAS number:
  EUPAS23356
• Study ID:
  24100
• Official title and acronym:
  Multinational Observational Database Study on Imminent Osteoporotic Fracture Risk: Stage 1 (IFRISK)
• DARWIN EU® study:
  No
• Study countries:
  Denmark

  Spain

  United Kingdom
• Study description:
  Osteoporosis (OP) is a systemic skeletal disease characterized by low bone mass and bone structure deterioration leading to increased fracture risk. The main clinical complication of OP is increased susceptibility to fractures due to bone fragility. A number of guidelines propose oral bisphosphonates (BP) as first-line therapies to prevent fragility fractures in osteoporotic patients, and aim at reducing the risk of fractures by 50%. Some studies have been previously conducted and identified risk factors for imminent fracture in OP patients under BP therapy. However, some discrepancies were also found across studies.Another approach to early identify patients at higher risk of imminent fracture while under BP treatment is to use one of the predictive tools derived and validated in untreated populations, and to modify/calibrate them as needed. The QFracture risk score is a predictive tool derived in naïve patients for long-term risk fracture, that has been validated three times and updated in 2012. QFracture can also model 1-year imminent fracture risk, but its validity for such prediction has not been tested to date. The objectives of the study are:Primary: to undertake a comprehensive descriptive analysis of the six proposed high fracture risk subcohorts, in regards with clinical, social and socio-economic characteristics, and to estimate the 1-year and 2-year fracture incidence rates and cumulative incidence functions over time in the six defined subcohorts Secondary: to conduct an external validation of QFracture risk score in the six predefined high risk subcohorts (see below) for 1-year imminent fracture prediction, to estimate 1-year and 2-year incidence rates of fatal fracture, rates (in patients with linked hospital data available) of fracture-related hospitalizations, and mortality, and to study the anti-osteoporotic drug exposure during the follow-up period.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences (NDORMS), University of Oxford

United Kingdom

Centre for Statistics in Medicine

University of Southern Denmark (SDU)

Denmark

University of Southern Denmark Odense, Denmark, Centre for Statistics in Medicine, NDORMS, University of Oxford Oxford, United Kingdom, SIDIAP, Idiap Jordi Gol, Universitat Autonoma de Barcelona Barcelona, Spain

Study timelines

Date when funding contract was signed

Planned: 02/01/2017

Actual: 10/05/2017

Study start date

Planned: 01/10/2017

Actual: 01/10/2017

Data analysis start date

Planned: 01/02/2018

Actual: 01/02/2018

Date of final study report

Planned: 31/10/2018

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

UCB Biopharma

Regulatory

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