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


Trial Overview

StatusConditionSponsor/Collaborator(s)First ReceivedLast ChangedVerification Date
Active, not recruiting Osteoporosis; Vertebral Fracture University of Bristol Other April 18, 2007 April 24, 2009 April 2009

Study TypeStudy DesignPhaseEnrollmentStart DateEnd Date
Interventional Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening N/A 3860 September 2007 -

Locations

FacilityAddressContactPhoneEmailStatus
Bristol Primary Care Trust (PCT) Bristol BS2 8EE United Kingdom - - - -

Intervention

TypeInterventionDescription
Procedure Clinical assessment +/- radiography Clinical assessment: height loss, history of fracture, Margolis pain score, rib/pelvis distance

Outcome

TypeMeasureTime FrameSafety 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

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)

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

GenderMinimum AgeMaximum AgeHealthy Volunteers
Female - 80 Years Accepts Healthy Volunteers

Inclusion Criteria:

- Female

- Aged 65-80 years

- Registered with a GP practice within Bristol Primary Care Trust (PCT)