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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Emma Clark, University of Bristol
ClinicalTrials.gov Identifier:
NCT00463905
First received: April 18, 2007
Last updated: December 3, 2014
Last verified: December 2014
History of Changes
  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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Bristol:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00463905

Locations
United Kingdom
Bristol Primary Care Trust (PCT)
Bristol, United Kingdom, BS2 8EE
Sponsors and Collaborators
University of Bristol
Investigators
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
Wounds and Injuries
Bone Diseases, Metabolic
 Bone Diseases
Musculoskeletal Diseases
Spinal Injuries
Back Injuries

ClinicalTrials.gov processed this record on September 28, 2016