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

NCT ID: NCT00463905

Last Updated: 2014-12-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 3200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2011-08-31

Brief Summary

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.

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.

Conditions

Osteoporosis; Vertebral Fracture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: DOUBLE

Study Groups

1

Current management for identifying postmenopausal women with osteoporotic vertebral fractures in primary care i.e. nothing

Group Type: NO_INTERVENTION

No interventions assigned to this group

2

Intervention arm: simple clinical assessment to identify high risk 30% (approximately) who will then be offered lateral thoraco-lumbar X-rays

Group Type: EXPERIMENTAL

Clinical assessment +/- radiography

Intervention Type: PROCEDURE

Clinical assessment: height loss, history of fracture, Margolis pain score, rib/pelvis distance

Interventions

Clinical assessment +/- radiography

Clinical assessment: height loss, history of fracture, Margolis pain score, rib/pelvis distance

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• None

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Bristol

OTHER

Sponsor Role: lead

Responsible Party

Emma Clark

Consultant Senior Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Emma M Clark, MBBS, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Bristol

Locations

Bristol Primary Care Trust (PCT)

Bristol, , United Kingdom

Countries

United Kingdom

References

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.

Reference Type: BACKGROUND

PMID: 22107913 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21810994 (View on PubMed)

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 (COSHIBA). J Bone Miner Res. 2012 Mar;27(3):664-71. doi: 10.1002/jbmr.1478.

Reference Type: RESULT

PMID: 22113935 (View on PubMed)

Other Identifiers

SMED RJ4783

Identifier Type: -

Identifier Source: org_study_id