NCT00463905

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 18, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 20, 2007

Completed
5 months until next milestone

Study Start

First participant enrolled

October 1, 2007

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

December 4, 2014

Status Verified

December 1, 2014

Enrollment Period

1.7 years

First QC Date

April 18, 2007

Last Update Submit

December 3, 2014

Conditions

OsteoporosisVertebral Fracture

Keywords

osteoporosisvertebral fracturesrandomised controlled trialscreening

Outcome Measures

Primary Outcomes (1)

  • The change in proportion of women aged 65-80 years prescribed bisphosphonates or other drugs in intervention arm compared with control arm

    2 years

Secondary Outcomes (7)

  • Number of extra VFs identified by risk-factor assessment tool

    2 years

  • Assessment of difference in indications for bisphosphonate prescribing after intervention

    2 years

  • Assessment of compliance

    2 years

  • Assessment of quality of life

    2 years

  • Economic analysis to assess cost-effectiveness of intervention

    2 years

  • +2 more secondary outcomes

Study Arms (2)

1

NO INTERVENTION

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

2

EXPERIMENTAL

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

Interventions

Clinical assessment +/- radiographyPROCEDURE

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

2

Eligibility Criteria

Age65 Years - 80 Years
Sexfemale
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bristol Primary Care Trust (PCT)

Bristol, BS2 8EE, United Kingdom

Location

Related Publications (3)

  • 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.

    PMID: 22107913BACKGROUND

  • 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.

    PMID: 21810994BACKGROUND

  • 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.

    PMID: 22113935RESULT

MeSH Terms

Conditions

OsteoporosisSpinal Fractures

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesSpinal InjuriesBack InjuriesWounds and InjuriesFractures, Bone

Study Officials

  • Emma M Clark, MBBS, PhD

    University of Bristol

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Senior Lecturer

Study Record Dates

First Submitted

April 18, 2007

First Posted

April 20, 2007

Study Start

October 1, 2007

Primary Completion

June 1, 2009

Study Completion

August 1, 2011

Last Updated

December 4, 2014

Record last verified: 2014-12

Locations

GB(1)