Osteoporosis Clinical Trial
Official title:
Population-Based Normative Database for HR-pQCT-Based Distal Radius and Tibia Strength Assessment in Switzerland
A novel methodology was recently developed and validated by the applicants to compute bone
strength at the distal radius and tibia using second-generation HR-pQCT reconstructions. The
methodology is expected to improve significantly the assessment of bone fracture risk in
idiopathic and secondary osteoporosis, but no reference data and no reproducibility data are
available.
The objective of the study is the determination of the sex- and age-specific distributions of
accurate distal radius and tibia strength assessed by HR-pQCT in the Swiss population.
Objective: De novo determination of sex- and age-specific reference intervals for vBMD, bone
architecture, and bone strength assessed by 3D HR-pQCT with a resolution of 61 µm (Xtreme CT
II, Scanco Medical, Brütisellen, Switzerland) in the Swiss population.
Design: Population-based, age- and sex-stratified, cross-sectional study in a single centre.
Study Size: For the main part, 480 valid data sets will be needed for two age reference
intervals for both women and men. The number of double/triple stack scans will be between 1
and 3 depending on graded motion artefacts.
Among the 120 participants of each reference interval, 21 will be needed to assess
reproducibility. For these volunteers, the number of double/triple stack scans will be equal
to 3.
Project Assessments, Procedures: participant demographics and physical activity will be
obtained and the validated Swiss FRAX questionnaire will be filled to determine the
epidemiology-based 10-year fracture risk. Grip strength will be measured. A DXA measurement
at the hip will be done according to the standard protocol of the Universitätspoliklinik für
Osteoporose. For participants at elevated vertebral fracture risk, lateral and
antero-posterior DXA of the spine will be added for vertebral fracture assessment (VFA) and
spine areal bone mineral density (aBMD). The HR-pQCT examination per se consists then of up
to 3 repeated double stack scans at the distal radius and triple stack scans at the distal
tibia.
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