Date of ISAC Approval:
Osteoporosis is a condition related to fragile bones and increased likelihood of bone fractures, which is known to be common in post-menopausal women. Some interventional and observational studies have suggested a relationship between osteoporosis and risk of heart attacks and stroke in elderly people. This is suggested for patients under treatment for osteoporosis or those who have had an osteoporotic fracture. However, no previous study has assessed this relationship in a real-world setting. Meanwhile, there are several risk assessment tools for both cardiovascular diseases and osteoporotic fractures. We aim in this study to investigate the potential relationship between these diseases. For this study we will include all female patients registered in the CPRD database between 2006 and 2019 who had a fracture when they were aged 50 years or more. Two well-known models developed in British populations will be used in this study to calculate patients' risk of having a bone fracture or heart attack/stroke. These models will use the clinical characteristics and medical diagnoses of patients in the 12-month period before the fracture, and the distribution of heart attack/stroke and fracture risk in different patient populations will be presented for further exploration.
STUDY OBJECTIVE: To explore and visualise the distribution of risk of cardiovascular diseases and osteoporotic fractures in a female post-fracture population. METHODS/DESIGN: This will be a cross-sectional study. Women registered in CPRD for at least 12 months during the study period will be included if they have an incident fracture while they are aged 50 years or more. Two established clinical risk prediction tools (QRisk for cardiovascular diseases and QFracture for osteoporotic fractures) will be applied at the date of the incident fracture to all patients based on the demographic and clinical data in the 12-month period before fracture date. Risk distribution for diseases in total population and various sub-populations will be presented visually for exploration. IMPORTANCE: The results of the study will help in hypothesis generation regarding the potential risk relationships between cardiovascular diseases and osteoporotic fractures. Given the potential hazardous effects of some anti-osteoporotic treatments on cardiovascular diseases, identification of patients at high risk of fracture but low risk of cardiovascular diseases is important for targeting with new medications.
Health Outcomes to be Measured:
Predicted risk of cardiovascular diseases and osteoporotic fractures, using two established clinical risk prediction tools, in a large population of patients with incident fractures.
Dr Alireza Moayyeri - Chief Investigator - UCB Pharma SA - UK
Dr Alireza Moayyeri - Corresponding Applicant - UCB Pharma SA - UK
Emese Toth - Collaborator - UCB Biopharma SRL - Belgium Headquarters
Victor Kiri - Collaborator - UCB BioSciences, Inc.