Studying calcaneus microarchitecture with teriparatide treatment

• Research type

  Research Study

• Full title

  Can calcaneum scans with high-resolution peripheral quantitative computer tomography detect teriparatide-induced changes in bone density and microarchitecture?

• IRAS ID

  182765

• Contact name

  Louis M Metcalf

• Contact email

  lmmetcalf1@sheffield.ac.uk

• Sponsor organisation

  SHEFFIELD TEACHING HOSPITALS NHS FOUNDATION TRUST

• Duration of Study in the UK

  1 years, 10 months, 28 days

• Research summary

  The heel bone (calcaneus) is located at a site that is accessible for bone scanning. Calcaneus strength (defined by bone mass and structure) has been found to change in response to physical activity/inactivity and drug treatments for osteoporosis (low bone strength). However, current methods provide limited detail on bone mass and structure and have poor accuracy. We have developed a new way to measure calcaneus strength using high-resolution X-ray imaging (XtremeCT), which may overcome these limitations. Our new method has been developed in human cadavers and needs to be tested in living participants.

  The study is split into two parts:
  1. Pilot Study
  This is a single-visit study based at the Northern General Hospital, recruiting postmenopausal women. We will monitor patient comfort during the XtremeCT scans of the calcaneus to help optimise participant comfort for the Main Study.

  2. Main Study
  This is an observational, long-term study based at the Northern General Hospital, recruiting postmenopausal women with osteoporosis to determine whether calcaneus bone strength changes with a bone-forming treatment (teriparatide). Teriparatide is prescribed to lower fracture risk. Participants will be starting teriparatide treatment following a consultation at the Metabolic Bone Centre.
  Participants will be required to attend the Clinical Research Facility on two occasions:
  Visit 1 (week 0) - Informed consent, XtremeCT scans of the calcaneus and lower leg
  Visit 2 (week 26) - XtremeCT scans of the calcaneus and lower leg

  To our knowledge and the device manufacturer, calcaneus bone strength has not been assessed using this method. We will use data collected from these will inform future research studies that aim to measure how exercise may interacts with drug treatments to prevent bone fractures. This could lead to lower doses of drug treatments prescribed to patient, which may lower side effects and improve treatment cost-effectiveness.

• REC name

  Yorkshire & The Humber - Sheffield Research Ethics Committee

• REC reference

  15/YH/0401

• Date of REC Opinion

  1 Oct 2015

• REC opinion

  Further Information Favourable Opinion