3D Imaging of the Hip Using DXA
Condition: Osteoporosis; Low-energy Trauma Fracture
MeSH terms: Osteoporosis; Fractures, Bone
Study type: Observational

Summary: 
      The study aims to determine the efficacy and best methods for predicting hip fractures and
      diagnosing post-menopausal osteoporosis using three dimensional structural engineering models
      (SEMs) of proximal femoral bone produced using a Hologic Discovery duel-energy x-ray
      absorptiometry scanner and Hologic's new 3D Hip(TM) software in comparison to three
      dimensional SEMs produced using quantitative computed tomography - the current gold standard.
    

Detailed description: 
      Bone mineral density (BMD) measurements by dual-energy x-ray absorptiometry (DXA) have been
      available to the clinician for the past 20 years and their use forms the basis of current
      clinical practice guidelines. The measurements are very useful, but they could be improved
      upon by taking into account the third dimension of bone (depth) and the distribution of
      mineral within bone. The value of a diagnostic test depends greatly on the strength of
      association of the measurement with the outcome. If we find that our new approach strengthens
      the ability of hip DXA measurements to predict fracture then we will have a greatly improved
      diagnostic test and so can better identify those patients we should treat. Further, such a
      test would allow better evaluation of new therapies for osteoporosis, particularly those that
      may alter bone geometry, including anabolic agents such as teriparatide.

      Patients attending for study visits will complete a basic questionnaire to collect
      information on their bone health and lifestyle (the current Metabolic Bone Centre standard
      questionnaire). Patients will also undergo DXA scans of their hips on a Hologic Discovery DXA
      machine using a new 3D imaging technique called '3D HipTM'. Hologic will process 3D HipTM
      scans and provide us with volumetric dataset of the scans before they provide us with a high
      performance PC and software for us to do the process on-site. They have already installed the
      software upgrade and necessary hardware to our Discovery densitometry system to enhance the
      3D HipTM capability. Patients will attend for a CT scan of their hip at the medical imaging
      department of the Northern General Hosptial as per standard practice.

      50 postmenopausal women who have recently suffered a hip fracture will be recruited to the
      study. 50 postmenopausal age matched controls will also be recruited. Subjects will give
      informed consent and a study visit will be arranged for them to attend for a DXA scan and a
      CT scan. At the study visit basic demographic data and a brief medical history will be
      collected on study specific Case Report Forms (CRF).

      The intended outcomes of the study are 1) To establish the diagnostic accuracy for hip
      fracture of the 3D HipTM and SEMs derived from the 3D HipTM, and to determine how much better
      the 3D HipTM is over the traditional 2D DXA in a case controlled study. 2) To compare three
      dimensional SEMs of the proximal femur derived from 3D Hip(TM) against simulated SEMs derived
      using quantitative computed tomography.
    

Intervention name(s): DXA scan of hip; CT scan of hip
Intervention type(s): Device; Device
Intervention description(s): Dual-energy X-ray Absorptiometry scan; Computed Tomography scan
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Community Sample Subjects recruited from A+E attendances/fracture clinics at Sheffield
        hospitals
      
Keywords: Osteoporosis; Fracture; DXA; Dual energy x-ray absorptiometry; Computed tomography; 3D DXA