Ignite Creation Date:
2024-05-06 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 12:28 PM
Study NCT ID:
NCT03219099
Status:
UNKNOWN
Last Update Posted:
2018-10-23
First Post:
2017-07-13
Brief Title:
Normative Database for HR-pQCT-Based Radius and Tibia Strength
Sponsor:
Insel Gruppe AG University Hospital Bern
Organization:
Insel Gruppe AG University Hospital Bern
Study Overview
Official Title:
Population-Based Normative Database for HR-pQCT-Based Distal Radius and Tibia Strength Assessment in Switzerland
Status:
UNKNOWN
Status Verified Date:
2018-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NODARATIS
Brief Summary:
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
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
Detailed Description:
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 doubletriple 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 doubletriple 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
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 doubletriple 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 doubletriple 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None