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

3. december 2014 opdateret af: Emma Clark, University of Bristol

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)

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

3200

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

65 år til 80 år (Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Screening
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: 1
Current management for identifying postmenopausal women with osteoporotic vertebral fractures in primary care i.e. nothing
Eksperimentel: 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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
The change in proportion of women aged 65-80 years prescribed bisphosphonates or other drugs in intervention arm compared with control arm
Tidsramme: 2 years
2 years

Sekundære resultatmål

Resultatmål
Tidsramme
Number of extra VFs identified by risk-factor assessment tool
Tidsramme: 2 years
2 years
Assessment of difference in indications for bisphosphonate prescribing after intervention
Tidsramme: 2 years
2 years
Assessment of compliance
Tidsramme: 2 years
2 years
Assessment of quality of life
Tidsramme: 2 years
2 years
Economic analysis to assess cost-effectiveness of intervention
Tidsramme: 2 years
2 years
Assessment of impact on fractures
Tidsramme: 2 years
2 years
Assessment of whether algorithm based qualitative (ABQ) semi-quantitative method of analyzing X-rays is better than simple inspection in identifying vertebral fractures
Tidsramme: 2 years
2 years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Bristol

Efterforskere

  • Ledende efterforsker: Emma M Clark, MBBS, PhD, University of Bristol

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. oktober 2007

Primær færdiggørelse (Faktiske)

1. juni 2009

Studieafslutning (Faktiske)

1. august 2011

Datoer for studieregistrering

Først indsendt

18. april 2007

Først indsendt, der opfyldte QC-kriterier

19. april 2007

Først opslået (Skøn)

20. april 2007

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

4. december 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. december 2014

Sidst verificeret

1. december 2014

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • SMED RJ4783

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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