The BLAST OFF Study - Version 1.0
Research type
Research Study
Full title
The BLAST OFF (Bisphosphonate aLternAtive regimenS for the prevenTion of Osteoporotic Fragility Fractures) Study.
IRAS ID
271732
Contact name
Opinder Sahota
Contact email
Sponsor organisation
Nottingham University Hospitals NHS Trust
Duration of Study in the UK
1 years, 11 months, 31 days
Research summary
Summary of Research
Osteoporosis is a condition where bones become weak and fragile and can easily break. Suffering from one fragility fracture doubles your chance of having another. These fractures can affect a person’s life significantly and contribute to significant costs to the UK health service.Bisphosphonates are used to treat osteoporosis and help prevent fractures. The most commonly used bisphosphonate treatment is Alendronate, but taking it correctly is complicated and side-effects are common. Therefore only 1 in 4 people continue with Alendronate beyond 2 years. There are different forms of bisphosphonates that can be given in different ways and frequencies and may be more acceptable and tolerated by patients.
The study will look at how effective different bisphosphonate regimens are compared to Alendronate at preventing fractures, whether the reduction in fracture risk can be achieved at reasonable financial cost and establish acceptability of different approaches to patients.
The study will be completed in 3 stages. Stage 1A will update a systematic review to inform which regimens are most effective at reducing fractures and provide the best value for money. Stage 1B will consist of qualitative semi-structured interviews from a sample of stakeholders in receipt of or involved in the delivery of different bisphosphonate regimens, in order to identify which regimens are most acceptable to patients. Stage 2 will use focus groups and workshops to discuss uncertainties from Stage 1 and identify the most important outstanding questions for future research.
This ethical review and information provided relates to Stage 1B. Stage 1A does not involve participants so does not require ethical review. Stage 2 will be conducted by the Royal Osteoporosis Society. Participants will not be invited via NHS organisations and no identifiable information will be collected. Use of the Health Research Authority decision tool identifies Stage 2 does not require ethical review.
Summary of Results
Background
Bisphosphonates are drug treatments commonly used to treat osteoporosis. Alendronate (ALN) is the most used, and is taken by mouth, weekly at a specific time of week, which can be challenging. Less than 1 in 4 people continue this treatment beyond 2 years. Alternative bisphosphonates are available, which vary in frequency and how they are administered. The most acceptable and best value for money regimen is unclear.
Aim
Our aim was to determine how effective alternative bisphosphonates are compared to ALN at preventing fractures and whether reduction in fracture risk was achieved at a reasonable financial cost, but acceptable to patients.
Design and methods
The study was conducted in two stages, stage 1A and 1B in parallel, followed by stage 2.
• Stage 1A: a review of the published evidence on patients' and doctors' views, experiences and preferences regarding different bisphosphonate treatment regimens, followed by interviews with patients and healthcare professionals• Stage 1B: an update of an existing study how effective bisphosphonates are in preventing fragility fractures caused by osteoporosis, and whether they are good value for money
• Stage 2: identification of questions that need to be answered about the effectiveness and acceptability of bisphosphonate treatments
Results
Taking bisphosphonate medication often involves quite a lot of effort by patients, particularly when taking ALN tablets. A yearly infusion of zoledronate (ZOL) treatment was more acceptable, easier to engage with and the most effective treatment compared to ALN. However the cost of administering ZOL in hospital made ALN better value for money.
Conclusions
Bisphosphonates are effective in reducing the risk of fracture, but 'continuing with treatment', particularly ALN tablets remains a challenge. A yearly infusion of ZOL offers an acceptable and effective treatment, but further research is needed into supporting patients and healthcare professionals to making decisions about the various treatments and the benefit and cost saving of administering ZOL outside hospital, in the community.REC name
North West - Preston Research Ethics Committee
REC reference
19/NW/0714
Date of REC Opinion
23 Dec 2019
REC opinion
Further Information Favourable Opinion