Defining patient groups at short-term high risk of fracture and evaluating current practice of osteoporosis treatment and rate of different fractures and cardiovascular events in these patient groups

Date of ISAC Approval: 
01/08/2018
Lay Summary: 
Medical research has enabled us to identify patients with fragile bones (disease known as osteoporosis) who are at high risk of fracture in the next 10 years. However, we are still unable to predict risk of fracture in shorter time horizons (e.g. a 1-year or 2-year periods). Defining patient groups at high short-term (imminent) risk of fracture could be useful for providing stronger/faster-acting treatments to these patients. This has an important impact on decision making of clinicians taking care of these patients. We therefore aim to define patient groups at potentially high imminent risk of fractures, and to evaluate the current practice of osteoporosis treatment in these patients. For this, we will define several patient groups within the CPRD dataset at the start of year 2015 (based on their characteristics such as recorded diagnosis of osteoporosis or history of specific types of fracture). The rate of fractures and number of patients receiving osteoporosis treatment in the next 2 years (i.e. until end of 2016) will then be calculated and compared between different groups. Safety concerns about cardiovascular problems (like heart attack and stroke) will also be assessed for all these patients.
Technical Summary: 
Patients at short-term (i.e. in 1- or 2-years) high risk of fracture (imminent risk) can be targeted for stronger/faster-acting treatments. Hence, we aim to define several patient populations with imminent fracture risk and to compare 1) incident fracture rates; 2) osteoporosis treatment; 3) cardiovascular events (myocardial infarction and stroke) in these populations. We will use CPRD data linked to Hospital Episode Statistics (HES) inpatient data and Office of National Statistics (ONS) mortality data. All female patients aged 50+ on 1/1/2015 and registered in CPRD for a minimum of 1 year will be evaluated and assigned to a 'general cohort'. Several sub-cohorts with imminent fracture risk will be defined based on diagnosis of osteoporosis or the type and number of fractures before 1/1/2015. Patients can be eligible to be included in more than one of these cohorts. Demographics, clinical characteristics, comorbidities and medications will be recorded for all patients at the baseline (i.e. 1/1/2015). Patients will be followed through linked CPRD-HES-ONS data until 31/12/2016, and rate of incident fractures, number of patients treated for osteoporosis, and rate of cardiovascular events (myocardial infarction/stroke/cardiovascular death) in 1- and 2-year follow-up periods will be calculated and presented for different cohorts.
Health Outcomes to be Measured: 
Osteoporotic fractures Osteoporosis treatment Cardiovascular events (stroke, MI, death)
Collaborators: 

Dr Alireza Moayyeri - Chief Investigator - UCB Pharma SA - UK
Dr Alireza Moayyeri - Corresponding Applicant - UCB Pharma SA - UK
Ms Corinna Hong - Collaborator - UCB Pharma SA - UK
Dr Daniel Prieto-Alhambra - Collaborator - University of Oxford
Emese Toth - Collaborator - UCB Biopharma SPRL - Belgium Headquarters
Mr John Logan - Collaborator - UCB Pharma SA - UK
Mr Paul McDwyer - Collaborator - UCB Biopharma SPRL - Belgium Headquarters
Victor Kiri - Collaborator - UCB BioSciences, Inc.

Linkages: 
HES Admitted;ONS;Patient IMD