Risk of Osteonecrosis of the Jaw in Female Users of Osteoporosis Treatments

Study type
Protocol
Date of Approval
Study reference ID
23_003182
Lay Summary

More than 2.5 million females in the UK are at risk for fractures caused by weakened bones (osteoporosis) and may benefit from treatment to prevent these fractures from occurring. One serious, but rare, side effect associated with some osteoporosis treatments is osteonecrosis of the jaw, a condition where the bone in the jaw weakens and dies. It is hard to get a good estimate of how often females with osteoporosis experience osteonecrosis of the jaw as the event is rare and there are few specific diagnosis codes for this condition. In a previous study, we evaluated the potential for using CPRD and HES (hospital) data together to create definitions for probable and possible cases of osteonecrosis of the jaw. In this study we will evaluate the risk of probable and possible osteonecrosis of the jaw according to the type of osteoporosis treatment as well as the total amount of osteoporosis drug received. The results of this study, though derived from patients in England and Wales, will be generalizable to the wider United Kingdom patient population and will provide valuable information to patients and clinicians on risk of osteonecrosis of the jaw when deciding between osteoporosis treatments.

Technical Summary

More than 2.5 million females in the UK are at risk for osteoporotic fractures and may benefit from treatment to prevent these fractures from occurring. Osteonecrosis of the jaw (ONJ) is a known adverse event associated with use of some osteoporosis treatments (bisphosphonates and denosumab). However, little is known about how the risk of ONJ varies between treatments, dose and duration of treatment, and use of concomitant medications. Under RDG # 21_000685, we developed an algorithm for selecting probable and possible cases of ONJ using information present in CPRD and linked HES records. In this study we will match osteonecrosis cases to up to 10 patients without osteonecrosis from the same population of female users of osteoporosis treatments by source (GOLD vs Aurum), age, calendar time and disease severity. We will then use conditional logistic regression to estimate the odds of ONJ by osteoporosis treatment including by cumulative dose, duration, combination treatments and concomitant medications (ie., steroids, hormone replacement therapy, immunosuppressants) compared with the lowest quintile of cumulative dose of alendronate use. The results of this study, though derived from patients in England and Wales, will be generalizable to the wider United Kingdom patient population and will provide valuable information to patients and clinicians on risk of ONJ when deciding between osteoporosis treatments.

Health Outcomes to be Measured

Osteonecrosis (any site); osteonecrosis of the jaw

Collaborators

Susan Jick - Chief Investigator - BCDSP - Boston Collaborative Drug Surveillance Program
Rebecca Persson - Corresponding Applicant - BCDSP - Boston Collaborative Drug Surveillance Program
Catherine Vasilakis-Scaramozza - Collaborator - BCDSP - Boston Collaborative Drug Surveillance Program
Katrina Hagberg - Collaborator - BCDSP - Boston Collaborative Drug Surveillance Program

Former Collaborators

Emma Pranschke - Collaborator - BCDSP - Boston Collaborative Drug Surveillance Program

Linkages

HES Admitted Patient Care