Blastoff Study (Bisphosphonate aLternAtive regimenS for the prevenTion of Osteoporotic Fragility Fractures)
This projects aims to determine how effective alternative bisphosphonates are compared to oral Alendronate at preventing fractures and whether reduction in fracture risk is achieved at a reasonable financial cost, but acceptable to patients.
Duration: March 2019 to July 2024
Funder: NIHR
Partners:
Nottingham University Hospitals NHS Trust, University of Nottingham, Royal Osteoporosis Society, Nottingham Osteoporosis Support Group, Sheffield Teaching Hospitals NHS Trust, University of Oxford.
CHILL investigators:
Dr Simon Bishop
Research summary
Background:
Osteoporosis is a condition where the bones become weak, are described as fragile and can easily break (fracture). When a person has suffered one fragility fracture, the risk of sustaining another is high. Bisphosphonates are medicines prescribed for osteoporosis that reduce the risk of fracture. Alendronate is the bisphosphonate that is most commonly used and has to be taken weekly, at a specific time of day, which can be challenging for some patients to follow (treatment compliance). Less than 1 in 4 people continue this treatment (treatment persistence) beyond 2 years. Alternative bisphosphonates are available, which vary in frequency and how they are administered (Zoledronate, for example is given an as an injection once every year). This approach has shown better compliance and longer-term persistence than weekly Alendronate, although the most acceptable and best value for money regimen remains unclear.
Design and methods:
The study will be conducted in two stages, stages 1A and 1B in parallel, followed by stage 2. Stage 1A-we plan to update an existing study on the effectiveness of and value for money provided by bisphosphonates for the prevention of fragility fractures published in 2016 which has informed current national guidelines. As part of this we will also conduct a more comprehensive review of studies which have assessed treatment compliance, long-term persistence and safety.
Stage 1B-we will undertake a review of the published evidence on patients’ and doctors’ views, experiences and preferences regarding different bisphosphonate treatment regimens, followed by more structured interviews to explore the findings from the review. Interviews will be conducted with patients, doctors and other healthcare members that provide the care of patients with osteoporosis, including people doing research.
Stage 2-we will identify questions that need to be answered about the effectiveness and acceptability of bisphosphonate treatment regimens. We will use the findings from Stage 1A and 1B to identify areas of uncertainty. We will then work with patients, doctors and researchers to generate research questions from these uncertainties, followed by a face-to-face event with a nationally representative group of patients, doctors and other healthcare workers/managers to rank these research questions in order of importance.
Patient and public involvement:
We are working closely with the Royal Osteoporosis Society (ROS) and the Nottingham ROS (NotROS) Support Group, who together have influenced the design of this application, choice of study outcomes and will be involved throughout the study.
Outputs:
This study will benefit patients, clinicians and the NHS by identifying: Which bisphosphonate treatment regimens are most effective at reducing fractures, provide value for money and are acceptable to patients. What patients, clinicians and researchers think are the most important research priorities in this area.
Dissemination:
We will work with the NOS to disseminate our results to policy makers, healthcare managers and professionals, researchers and PPI groups, through newsletters, websites, social media, research publications and national meetings.
