Evaluation of the Impact of a Case-finding Strategy for Vertebral Fractures (COSHIBA)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Osteoporosis Vertebral Fracture |
Procedure: Clinical assessment +/- radiography |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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) |
- 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 ] [ Designated as safety issue: No ]
- Number of extra VFs identified by risk-factor assessment tool [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Assessment of difference in indications for bisphosphonate prescribing after intervention [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Assessment of compliance [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Assessment of quality of life [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Economic analysis to assess cost-effectiveness of intervention [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Assessment of impact on fractures [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
| Enrollment: | 3200 |
| Study Start Date: | October 2007 |
| Study Completion Date: | August 2011 |
| Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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.
Eligibility| Ages Eligible for Study: | 65 Years to 80 Years |
| Genders 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:
- None
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00463905
| United Kingdom | |
| Bristol Primary Care Trust (PCT) | |
| Bristol, United Kingdom, BS2 8EE | |
| Principal Investigator: | Emma M Clark, MBBS, PhD | University of Bristol, UK |
More Information
Publications:
| Responsible Party: | Emma Clark, Consultant Senior Lecturer, University of Bristol |
| ClinicalTrials.gov Identifier: | NCT00463905 History of Changes |
| Other Study ID Numbers: | SMED RJ4783 |
| Study First Received: | April 18, 2007 |
| Last Updated: | December 3, 2014 |
| Health Authority: | United Kingdom: National Health Service |
Keywords provided by University of Bristol:
|
osteoporosis vertebral fractures randomised controlled trial screening |
Additional relevant MeSH terms:
|
Fractures, Bone Osteoporosis Spinal Fractures Back Injuries Bone Diseases |
Bone Diseases, Metabolic Musculoskeletal Diseases Spinal Injuries Wounds and Injuries |
ClinicalTrials.gov processed this record on February 25, 2015