Evaluation of the Impact of a Case-finding Strategy for Vertebral Fractures (COSHIBA)
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ClinicalTrials.gov Identifier: NCT00463905 |
Recruitment Status
:
Completed
First Posted
: April 20, 2007
Last Update Posted
: December 4, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Osteoporosis Vertebral Fracture | Procedure: Clinical assessment +/- radiography | Not Applicable |
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 (Clinical Trial) |
Actual Enrollment : | 3200 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Outcomes Assessor) |
Primary Purpose: | Screening |
Official Title: | 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) |
Study Start Date : | October 2007 |
Actual Primary Completion Date : | June 2009 |
Actual Study Completion Date : | August 2011 |
Arm | Intervention/treatment |
---|---|
No Intervention: 1
Current management for identifying postmenopausal women with osteoporotic vertebral fractures in primary care i.e. nothing
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Experimental: 2
Intervention arm: simple clinical assessment to identify high risk 30% (approximately) who will then be offered lateral thoraco-lumbar X-rays
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Procedure: Clinical assessment +/- radiography
Clinical assessment: height loss, history of fracture, Margolis pain score, rib/pelvis distance
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- 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 ]
- Number of extra VFs identified by risk-factor assessment tool [ Time Frame: 2 years ]
- Assessment of difference in indications for bisphosphonate prescribing after intervention [ Time Frame: 2 years ]
- Assessment of compliance [ Time Frame: 2 years ]
- Assessment of quality of life [ Time Frame: 2 years ]
- Economic analysis to assess cost-effectiveness of intervention [ Time Frame: 2 years ]
- Assessment of impact on fractures [ Time Frame: 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 ]

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Ages Eligible for Study: | 65 Years to 80 Years (Adult, Senior) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Female
- Aged 65-80 years
- Registered with a GP practice within Bristol Primary Care Trust (PCT)
Exclusion Criteria:

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): NCT00463905
United Kingdom | |
Bristol Primary Care Trust (PCT) | |
Bristol, United Kingdom, BS2 8EE |
Principal Investigator: | Emma M Clark, MBBS, PhD | University of Bristol, UK |
Publications of Results:
Other Publications:
Responsible Party: | Emma Clark, Consultant Senior Lecturer, University of Bristol |
ClinicalTrials.gov Identifier: | NCT00463905 History of Changes |
Other Study ID Numbers: |
SMED RJ4783 |
First Posted: | April 20, 2007 Key Record Dates |
Last Update Posted: | December 4, 2014 |
Last Verified: | December 2014 |
Keywords provided by Emma Clark, University of Bristol:
osteoporosis vertebral fractures randomised controlled trial screening |
Additional relevant MeSH terms:
Fractures, Bone Osteoporosis Spinal Fractures Wounds and Injuries Bone Diseases, Metabolic |
Bone Diseases Musculoskeletal Diseases Metabolic Diseases Spinal Injuries Back Injuries |