Osteoporosis Clinical Trial
— NODARATISOfficial title:
Population-Based Normative Database for HR-pQCT-Based Distal Radius and Tibia Strength Assessment in Switzerland
NCT number | NCT03219099 |
Other study ID # | UKO-2017-1 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | June 14, 2018 |
Est. completion date | May 2020 |
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.
Status | Recruiting |
Enrollment | 576 |
Est. completion date | May 2020 |
Est. primary completion date | May 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 20 Years to 100 Years |
Eligibility |
Inclusion Criteria: - Healthy volunteers aged 20 years or older living in Switzerland - Written informed consent Exclusion Criteria: - Psychological disorder or dementia in order to understand the informed consent and be able to fill the FRAX questionnaire - Implant or a fracture at the DXA and HR-pQCT measurement sites - Inability to keep the extremities still for the few minutes of an HR-pQCT examination (e.g. Parkinson disease or spastic syndrome) - History of low trauma fracture - Known pregnancy or lactating women - History of hysterectomy and/or ovariectomy - Known metabolic bone disorders, such as osteogenesis imperfecta, Paget's disease or sclerosteosis (osteopenia or idiopathic osteoporosis are not exclusion criteria) - Ever use of one or more of the following bone active substances: bisphosphonates, RANKL-inhibitors (DENOSUMAB), selective estrogen receptors (SERMS) or parathormone/teriparatide - Ever use of oral glucocorticoids during more than 3 months or currently taking glucocorticoids |
Country | Name | City | State |
---|---|---|---|
Switzerland | University Hospital Inselspital | Bern |
Lead Sponsor | Collaborator |
---|---|
University Hospital Inselspital, Berne | University of Bern |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Bone strength at distal radius and tibia, assessed by HR-pQCT | Normative Database for HR-pQCT-Based Distal Radius and Tibia Strength in Swiss women and men | At baseline (cross-sectional, single timepoint for data collection) | |
Secondary | In-vivo reproducibility of radius strength calculations | 3 repeated double/ triple stack scans, after reposition, data collection within 1 hour at one single time point | At baseline | |
Secondary | In-vivo reproducibility of tibia strength calculations | 3 repeated double/ triple stack scans, after reposition, data collection within 1 hour at one single time point | At baseline |
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