Osteoporosis Clinical Trial
— COSHIBAOfficial 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)
Verified date | December 2014 |
Source | University of Bristol |
Contact | n/a |
Is FDA regulated | No |
Health authority | United Kingdom: National Health Service |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 3200 |
Est. completion date | August 2011 |
Est. primary completion date | June 2009 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 65 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Female - Aged 65-80 years - Registered with a GP practice within Bristol Primary Care Trust (PCT) Exclusion Criteria: |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Screening
Country | Name | City | State |
---|---|---|---|
United Kingdom | Bristol Primary Care Trust (PCT) | Bristol |
Lead Sponsor | Collaborator |
---|---|
University of Bristol |
United Kingdom,
Clark EM, Gould V, Morrison L, Ades AE, Dieppe P, Tobias JH. Randomized controlled trial of a primary care-based screening program to identify older women with prevalent osteoporotic vertebral fractures: Cohort for Skeletal Health in Bristol and Avon (COS — View Citation
Clark EM, Gould VC, Morrison L, Masud T, Tobias J. Determinants of fracture risk in a UK-population-based cohort of older women: a cross-sectional analysis of the Cohort for Skeletal Health in Bristol and Avon (COSHIBA). Age Ageing. 2012 Jan;41(1):46-52. doi: 10.1093/ageing/afr132. Epub 2011 Nov 21. — View Citation
Weston JM, Norris EV, Clark EM. The invisible disease: making sense of an osteoporosis diagnosis in older age. Qual Health Res. 2011 Dec;21(12):1692-704. doi: 10.1177/1049732311416825. Epub 2011 Aug 2. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The change in proportion of women aged 65-80 years prescribed bisphosphonates or other drugs in intervention arm compared with control arm | 2 years | No | |
Secondary | Number of extra VFs identified by risk-factor assessment tool | 2 years | No | |
Secondary | Assessment of difference in indications for bisphosphonate prescribing after intervention | 2 years | No | |
Secondary | Assessment of compliance | 2 years | No | |
Secondary | Assessment of quality of life | 2 years | No | |
Secondary | Economic analysis to assess cost-effectiveness of intervention | 2 years | No | |
Secondary | Assessment of impact on fractures | 2 years | No | |
Secondary | Assessment of whether algorithm based qualitative (ABQ) semi-quantitative method of analyzing X-rays is better than simple inspection in identifying vertebral fractures | 2 years | No |
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