Evaluation of the Impact of a Case-finding Strategy for Vertebral Fractures
Condition: Osteoporosis; Vertebral Fracture
MeSH terms: Osteoporosis; Fractures, Bone; Spinal Fractures
Study type: Interventional

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.
    

Detailed 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.
    

Intervention name(s): Clinical assessment +/- radiography
Intervention type(s): Procedure
Intervention description(s): Clinical assessment: height loss, history of fracture, Margolis pain score, rib/pelvis distance
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Screening
Keywords: osteoporosis; vertebral fractures; randomised controlled trial; screening