Normative Database for HR-pQCT-Based Radius and Tibia Strength (NODARATIS)
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|ClinicalTrials.gov Identifier: NCT03219099|
Recruitment Status : Recruiting
First Posted : July 17, 2017
Last Update Posted : October 23, 2018
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.
|Condition or disease|
|Osteoporosis Diagnoses Disease Fracture Bone Strength|
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.
|Study Type :||Observational|
|Estimated Enrollment :||576 participants|
|Official Title:||Population-Based Normative Database for HR-pQCT-Based Distal Radius and Tibia Strength Assessment in Switzerland|
|Actual Study Start Date :||June 14, 2018|
|Estimated Primary Completion Date :||May 2020|
|Estimated Study Completion Date :||May 2020|
- Bone strength at distal radius and tibia, assessed by HR-pQCT [ Time Frame: At baseline (cross-sectional, single timepoint for data collection) ]Normative Database for HR-pQCT-Based Distal Radius and Tibia Strength in Swiss women and men
- In-vivo reproducibility of radius strength calculations [ Time Frame: At baseline ]3 repeated double/ triple stack scans, after reposition, data collection within 1 hour at one single time point
- In-vivo reproducibility of tibia strength calculations [ Time Frame: At baseline ]3 repeated double/ triple stack scans, after reposition, data collection within 1 hour at one single time point
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03219099
|Contact: Kurt Lippuner, M.D.||+41 31 632 31 firstname.lastname@example.org|
|Contact: Anna Stuck, M.D.||+41 31 632 69 email@example.com|
|University Hospital Inselspital||Recruiting|
|Bern, Switzerland, 3010|
|Study Director:||Kurt Lippuner, M.D.||Department of Osteoporosis, Bern University Hospital, University of Bern, CH-3010 Bern, Switzerland|
|Study Director:||Philippe Zysset, Ph.D.||Institute of Surgical Technology and Biomechanics|