Exploring Efficacy, Cost Effectiveness and Experiences Related to Adherence of Different Bisphosphonate Regimens for the Prevention of Osteoporotic Fragility Fractures.
BLASTOFF
The BLAST OFF (Bisphosphonate aLternAtive regimenS for the prevenTion of Osteoporotic Fragility Fractures) Study
1 other identifier
observational
100
1 country
1
Brief Summary
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 (United Kingdom) 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 2 stages, Stage 1A and Stage 1B in parallel, followed by Stage 2. 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 bisphosphonate regimens are most acceptable to patients and the barriers to effective compliance and adherence. Stage 2 will use focus groups and workshops with stakeholders and commissioners to discuss uncertainties from Stage 1 and identify the most important outstanding questions for future research.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2020
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 18, 2020
CompletedFirst Posted
Study publicly available on registry
February 25, 2020
CompletedStudy Start
First participant enrolled
March 6, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2022
CompletedApril 25, 2023
April 1, 2023
1.3 years
February 18, 2020
April 24, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Views, experiences and preferences of patients, clinicians and researchers regarding different bisphosphonate treatment regimens.
Collected through conduction and analysis of semi-structured interviews.
40-50 minutes
Secondary Outcomes (3)
Effectiveness of different bisphosphonate regimens in preventing fragility fractures in adults.
24 months
Cost-effectiveness of different bisphosphonate regimens in preventing fragility fractures in adults.
24 months
Prioritised future research questions regarding the effectiveness and adherence profile of different bisphosphonate regimens in preventing fragility fractures in adults.
2-3 hours
Study Arms (8)
General Practitioner
General Practitioners working within primary care in the UK
Primary Care Patients
Patients cared for in primary care who started on oral bisphosphonates within the last 24 months for prevention of fragility fractures
Secondary Care Clinicians
Clinicians working in secondary care as specialists (e.g. nurses, consultants) involved in the treatment of osteoporosis
Secondary Care Patients
Patients cared for in secondary care receiving hospital based (intravenous) bisphosphonate treatments for prevention of fragility fractures who began treatment within the last 24 months
Clinical Academics
Clinical academics involved in osteoporosis research
Secondary Care Clinicians - Novel Care
Clinicians working in secondary care as specialists (e.g. nurses, consultants) from the osteoporosis service in Nottingham and Sheffield with insight into alternate bisphosphonate treatments
Secondary Care Patients - Novel Care
Patients cared for in secondary care receiving alternative bisphosphonate treatments for prevention of fragility fractures who began treatment within the last 24 months at the osteoporosis service in Nottingham or Sheffield
Commissioners
Commissioners involved in osteoporosis services
Interventions
A single qualitative interview about experiences of bisphosphonate regimens, as well as wider experiences of service quality and delivery.
Eligibility Criteria
Patients and stakeholders in receipt of or involved in the delivery of bisphosphonate treatment for the prevention of fragility fractures.
You may qualify if:
- Adults over the age of 18 with the ability to give informed consent and represent one of the following stakeholder groups:
- GPs
- Patients who started on oral bisphosphonates within the last 24 months for prevention of fragility fractures
- Secondary care specialist clinicians (nurses, consultants) involved in the treatment of osteoporosis.
- Patients receiving hospital based (intravenous) bisphosphonate treatments for prevention of fragility fractures who began treatment within the last 24 months
- Clinical academics involved in osteoporosis research
- Specialist clinicians (nurses, consultants) from the osteoporosis service in Nottingham and Sheffield with insight into alternate bisphosphonate treatments
- Patients receiving alternate bisphosphonate treatments for prevention of fragility fractures who began treatment within the last 24 months
- Commissioners involved in osteoporosis services
You may not qualify if:
- Patients who take bisphosphonate medicines for reasons other than osteoporosis or osteopenia, including patients with an active cancer, primary hyperparathyroidism and Paget's disease.
- Are unable to give informed consent
- Considered to be near to end of life.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Nottingham University Hospitals Trust, Queens Medical Centre
Nottingham, Nottinghamshire, NG7 2UH, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Opinder Sahota, Professor
Nottingham University Hospitals NHS Trust
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 18, 2020
First Posted
February 25, 2020
Study Start
March 6, 2020
Primary Completion
June 30, 2021
Study Completion
May 31, 2022
Last Updated
April 25, 2023
Record last verified: 2023-04
Data Sharing
- IPD Sharing
- Will not share
The datasets (whole transcripts) generated during and/or analysed during the current study are not expected to be made available due to participant confidentiality. Some anonymised statements may be available within the published results.