Epidemiology and burden of imminent subsequent fractures in postmenopausal women

Study type
Protocol
Date of Approval
Study reference ID
22_002498
Lay Summary

Osteoporosis is a bone loss disease that frequently affects women who have reached the menopause stage. A consequence of osteoporosis is an increased risk of fracture. Once a woman suffers a first fracture, she is likely to have a subsequent fracture within the next two years. The cost of treating fractures is expected to increase significantly due to an aging population. There is a lack of information on the health profile and demographics of these women suffering from subsequent fractures, how frequently subsequent fractures occur, and the cost and healthcare usage in women with subsequent fractures compared to women who have a single fracture or no fracture.

The purpose of this study is to 1) describe the demographics and health profile of women with subsequent fractures, 2) how often new cases of subsequent fractures occur among women who have had a first fracture, and 3) whether healthcare usage and costs differ among women with subsequent fracture, those who had a single fracture, or those who had no fracture.

This study will inform clinicians about the profile of women who have subsequent fractures, which can help with preventative strategies. It will also help understand how common subsequent fractures are, and the healthcare use and costs associated with managing these women in practice. Furthermore, this study will inform healthcare planners the potential resource allocation needed in treating subsequent fractures in osteoporosis.

Technical Summary

Amongst postmenopausal women, the objectives are to:
1) Describe the characteristics of women with an imminent subsequent fracture.
2) Describe the incidence of imminent subsequent fractures.
3) Estimate the impact of an imminent subsequent fracture on healthcare resource utilisation (HCRU) and direct costs.

This network cohort study will include women aged ≥50 years between April 2010 and March 2018 in six European countries. In the UK, primary care medical records from AURUM will be linked to hospital, deprivation, and mortality databases. Three cohorts are of interest. The target cohort includes women with a fracture and history of at least one fracture in the prior two years. Comparator cohort 1 includes women with a fracture and no history of fracture in the prior two years. Comparator cohort 2 includes women with no history of fracture.

For objectives 1 and 2, the characteristics of comparator cohort 1 will be described and the incidence of new cases of imminent subsequent fractures will be calculated. For objective 3, age and propensity score (PS) matching will be used to estimate the differences in HCRU and costs between the target cohort and comparator cohort 1, and between comparator cohort 1 and comparator cohort 2.

This study will inform clinicians and researchers:
1) The characteristics of women who are likely to have an imminent subsequent fracture and how common they are, supporting secondary fracture prevention programmes.
2) Identify the HCRU and costs associated with managing these women in practice, informing decision-making around healthcare service delivery and efficient use of limited resources in the system.
3) How well HCRU and costs are recorded both in the CPRD and across European countries, as well as whether it is feasible to utilise standardised data structure and content across countries via a common data model allowing for more efficient future analyses.

Health Outcomes to be Measured

Objective 1 is descriptive, but the outcome of interest for the cohort that will be described is the same as that of objective 2, i.e., an imminent subsequent fracture. An imminent subsequent fracture is defined as an incident (or new) fracture within 730 days of the index fracture.

For objective 3, the outcomes of interest are healthcare resource utilization (HCRU) and direct costs. HCRU will be measured during the 730 days post index date and it will include (i) number of visits to emergency room, inpatient, and outpatient regardless of cause, (ii) number of procedures (surgical or otherwise) and use of devices regardless of cause, (iii) length of stay for inpatient hospital spells regardless of cause, and (iv) costs of fracture-related procedures (e.g. open/closed reduction, fixation of fracture) and use of devices (e.g. brace, cast frame).

Collaborators

Trishna Rathod-Mistry - Chief Investigator - University of Oxford
Eng Hooi Tan - Corresponding Applicant - University of Oxford
Antonella Delmestri - Collaborator - University of Oxford
Gianluca Fabiano - Collaborator - University of Oxford
Lucy Njuki - Collaborator - University of Oxford
Mandickel Kamtengeni - Collaborator - University of Oxford
Rafael Pinedo-Villanueva - Collaborator - University of Oxford
Xihang Chen - Collaborator - University of Oxford

Former Collaborators

Christopher Maronga - Collaborator - University of Oxford
Mandickel Kamtengeni - Collaborator - University of Oxford

Linkages

HES Accident and Emergency;HES Admitted Patient Care;HES Outpatient;ONS Death Registration Data;Patient Level Index of Multiple Deprivation;Practice Level Index of Multiple Deprivation