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

NCT04283786 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2023-04-25

No results posted yet for this study

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.

Conditions

Interventions

OTHER

Qualitative Interview

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

Sponsors & Collaborators

  • University of Nottingham

    collaborator OTHER

  • Nottingham University Hospitals NHS Trust

    lead OTHER

Principal Investigators

  • Opinder Sahota, Professor · Nottingham University Hospitals NHS Trust

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-06
Primary Completion
2021-06-30
Completion
2022-05-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04283786 on ClinicalTrials.gov