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

NCT00463905 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3200

Last updated 2014-12-04

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

Clinical assessment +/- radiography

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

Sponsors & Collaborators

  • University of Bristol

    lead OTHER

Principal Investigators

  • Emma M Clark, MBBS, PhD · University of Bristol

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2009-06-30
Completion
2011-08-31

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00463905 on ClinicalTrials.gov