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Exploring Efficacy, Cost Effectiveness and Experiences Related to Adherence of Different Bisphosphonate Regimens for the Prevention of Osteoporotic Fragility Fractures. (BLASTOFF)

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ClinicalTrials.gov Identifier: NCT04283786
Recruitment Status : Not yet recruiting
First Posted : February 25, 2020
Last Update Posted : March 4, 2020
Sponsor:
Collaborator:
University of Nottingham
Information provided by (Responsible Party):
Nottingham University Hospitals NHS Trust

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.


Condition or disease Intervention/treatment
Osteoporosis Other: Qualitative Interview

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Study Type : Observational
Estimated Enrollment : 70 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: The BLAST OFF (Bisphosphonate aLternAtive regimenS for the prevenTion of Osteoporotic Fragility Fractures) Study
Estimated Study Start Date : March 2020
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
General Practitioner
General Practitioners working within primary care in the UK
Other: Qualitative Interview
A single qualitative interview about experiences of bisphosphonate regimens, as well as wider experiences of service quality and delivery.

Primary Care Patients
Patients cared for in primary care who started on oral bisphosphonates within the last 24 months for prevention of fragility fractures
Other: Qualitative Interview
A single qualitative interview about experiences of bisphosphonate regimens, as well as wider experiences of service quality and delivery.

Secondary Care Clinicians
Clinicians working in secondary care as specialists (e.g. nurses, consultants) involved in the treatment of osteoporosis
Other: Qualitative Interview
A single qualitative interview about experiences of bisphosphonate regimens, as well as wider experiences of service quality and delivery.

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
Other: Qualitative Interview
A single qualitative interview about experiences of bisphosphonate regimens, as well as wider experiences of service quality and delivery.

Clinical Academics
Clinical academics involved in osteoporosis research
Other: Qualitative Interview
A single qualitative interview about experiences of bisphosphonate regimens, as well as wider experiences of service quality and delivery.

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
Other: Qualitative Interview
A single qualitative interview about experiences of bisphosphonate regimens, as well as wider experiences of service quality and delivery.

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
Other: Qualitative Interview
A single qualitative interview about experiences of bisphosphonate regimens, as well as wider experiences of service quality and delivery.

Commissioners
Commissioners involved in osteoporosis services
Other: Qualitative Interview
A single qualitative interview about experiences of bisphosphonate regimens, as well as wider experiences of service quality and delivery.




Primary Outcome Measures :
  1. Views, experiences and preferences of patients, clinicians and researchers regarding different bisphosphonate treatment regimens. [ Time Frame: 40-50 minutes ]
    Collected through conduction and analysis of semi-structured interviews.


Secondary Outcome Measures :
  1. Effectiveness of different bisphosphonate regimens in preventing fragility fractures in adults. [ Time Frame: 24 months ]
    By analysis of published literature by systematic review.

  2. Cost-effectiveness of different bisphosphonate regimens in preventing fragility fractures in adults. [ Time Frame: 24 months ]
    Using a health economic model on data of published literature identified by systematic review

  3. Prioritised future research questions regarding the effectiveness and adherence profile of different bisphosphonate regimens in preventing fragility fractures in adults. [ Time Frame: 2-3 hours ]
    By stakeholder engagement workshops using the James Lind methodology.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients and stakeholders in receipt of or involved in the delivery of bisphosphonate treatment for the prevention of fragility fractures.
Criteria

Inclusion Criteria:

Adults over the age of 18 with the ability to give informed consent and represent one of the following stakeholder groups:

  1. GPs
  2. Patients who started on oral bisphosphonates within the last 24 months for prevention of fragility fractures
  3. Secondary care specialist clinicians (nurses, consultants) involved in the treatment of osteoporosis.
  4. Patients receiving hospital based (intravenous) bisphosphonate treatments for prevention of fragility fractures who began treatment within the last 24 months
  5. Clinical academics involved in osteoporosis research
  6. Specialist clinicians (nurses, consultants) from the osteoporosis service in Nottingham and Sheffield with insight into alternate bisphosphonate treatments
  7. Patients receiving alternate bisphosphonate treatments for prevention of fragility fractures who began treatment within the last 24 months
  8. Commissioners involved in osteoporosis services

Exclusion Criteria:

  1. Patients who take bisphosphonate medicines for reasons other than osteoporosis or osteopenia, including patients with an active cancer, primary hyperparathyroidism and Paget's disease.
  2. Are unable to give informed consent
  3. Considered to be near to end of life.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04283786


Contacts
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Contact: Research & Innovation, NUH NHS Trust 44 0115 9709049 researchsponsor@nuh.nhs.uk
Contact: Simon Bishop, Professor 44 0115 8466060 simon.bishop@nottingham.ac.uk

Sponsors and Collaborators
Nottingham University Hospitals NHS Trust
University of Nottingham
Investigators
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Principal Investigator: Opinder Sahota, Professor Nottingham University Hospitals NHS Trust
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Responsible Party: Nottingham University Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT04283786    
Other Study ID Numbers: 43961
First Posted: February 25, 2020    Key Record Dates
Last Update Posted: March 4, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description:

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.


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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nottingham University Hospitals NHS Trust:
bisphosphonates
systematic review
qualitative interviews
osteoporosis
Additional relevant MeSH terms:
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Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases