Trial Overview

Locations

Intervention

Outcome

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

Inclusion Criteria:

- Female

- Aged 65-80 years

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