Evaluation of the Impact of a Case-finding Strategy for Vertebral Fractures (COSHIBA)

December 3, 2014 updated by: Emma Clark, University of Bristol

Evaluation of the Impact of a Case-finding Strategy for Vertebral Fractures on Bisphosphonate and Other Drug Prescribing in Primary Care, Using the Cohort for Skeletal Health in Bristol and Avon (COSHIBA)

Postmenopausal women with vertebral fractures (VFs) represent an important target for secondary fracture prevention, but few of these patients come for clinical attention. Recent evidence suggests that screening postmenopausal women for clinical risk factors like height loss and fracture risk identifies those at high risk of prevalent VFs who should be referred for diagnostic X-rays, a strategy which is likely to prove cost effective. However, before being applied at a United Kingdom (UK)-wide level, it needs to be established that use of this strategy improves secondary fracture prevention, and that these benefits are achieved in a cost-effective manner. To examine these questions, a randomised-controlled-trial will be performed in which women aged 65-80 from general practitioner (GP)-practices in the intervention group will be invited for risk factor assessment, followed by referral for thoracolumbar X-ray where appropriate. The primary outcome will be a change in bisphosphonate or other drug prescribing between the intervention and control arms after six months.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study will use a randomised controlled trial to assess the impact of a case-finding strategy for vertebral fractures on bisphosphonate and other drug prescribing in primary care. A sample of postmenopausal women aged 65-80 years from Bristol will be invited to take part. They will be individually randomised into either the intervention or control arm in a 2:1 ratio in favour of controls. The participants in the intervention arm will attend their GP practice to receive a simple 15 minute assessment, and if found to be at high risk of vertebral fractures will have a thoracolumbar X-ray; those randomised to the control arm will receive current standard methods used to identify women at high risk of vertebral fractures (no active intervention). Follow-up will be for three years.

Baseline measurements will be taken from women in each arm via self-completion postal questionnaire, including current prescriptions of any bisphosphonate or other osteoporosis medication. The women in the intervention arm will attend their GP practice and receive a simple 15 minute assessment, and if found to be at high risk of vertebral fractures will have a thoracolumbar X-ray arranged for them. They will be given a leaflet on lifestyle interventions aimed to improve bone health. Women in the control arm will be sent the same leaflet. Post-intervention questionnaires will be sent to all women asking about fractures and current prescriptions of any bisphosphonate or other osteoporosis medication. The primary outcome will be the proportion of women prescribed medication for secondary fracture prevention in the intervention arm compared to the control arm. Secondary outcomes will include the proportion of fractures in the intervention versus control arm, and compliance with bisphosphonate or other drug prescribing.

This study will be performed subject to Research Ethics Committee (REC) approval, including any provisions of Site Specific Assessment (SSA), and local Research and Development approval. This study will be conducted in accordance with the Research Governance Framework for Health and Social Care and Good Clinical Practice.

Study Type

Interventional

Enrollment (Actual)

3200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Bristol, United Kingdom, BS2 8EE
        • Bristol Primary Care Trust (PCT)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 80 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Female
  • Aged 65-80 years
  • Registered with a GP practice within Bristol Primary Care Trust (PCT)

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 1
Current management for identifying postmenopausal women with osteoporotic vertebral fractures in primary care i.e. nothing
Experimental: 2
Intervention arm: simple clinical assessment to identify high risk 30% (approximately) who will then be offered lateral thoraco-lumbar X-rays
Procedure: Clinical assessment +/- radiography
Clinical assessment: height loss, history of fracture, Margolis pain score, rib/pelvis distance

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The change in proportion of women aged 65-80 years prescribed bisphosphonates or other drugs in intervention arm compared with control arm
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of extra VFs identified by risk-factor assessment tool
Time Frame: 2 years
2 years
Assessment of difference in indications for bisphosphonate prescribing after intervention
Time Frame: 2 years
2 years
Assessment of compliance
Time Frame: 2 years
2 years
Assessment of quality of life
Time Frame: 2 years
2 years
Economic analysis to assess cost-effectiveness of intervention
Time Frame: 2 years
2 years
Assessment of impact on fractures
Time Frame: 2 years
2 years
Assessment of whether algorithm based qualitative (ABQ) semi-quantitative method of analyzing X-rays is better than simple inspection in identifying vertebral fractures
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Bristol

Investigators

  • Principal Investigator: Emma M Clark, MBBS, PhD, University of Bristol

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

April 18, 2007

First Submitted That Met QC Criteria

April 19, 2007

First Posted (Estimate)

April 20, 2007

Study Record Updates

Last Update Posted (Estimate)

December 4, 2014

Last Update Submitted That Met QC Criteria

December 3, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMED RJ4783

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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