OsteoporosisNODARATISNCT03219099
Normative Database for HR-pQCT-Based Radius and Tibia Strength
An observational study of Osteoporosis and Diagnoses Disease, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis, Diagnoses Disease, Fracture
- How many people
- 576 participants
- Where
- 1 siteSwitzerland
- Study dates
- 14 Jun 2018to May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The project population are female and male healthy volunteers above 20 years old. Following international recommendations, the number of participants for the calculation of the reference intervals is set to 576. Among these, the assessment of reproducibility of the novel bone strength estimation methodology will be performed in 42 participants.
Who may be able to join
- Healthy volunteers aged 20 years or older living in Switzerland
- Written informed consent
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Inselspital
Bern, 3010
About this study
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.
Read the 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 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.
- Conditions
- Osteoporosis, Diagnoses Disease, Fracture, Bone Strength
- Medical subject headings
- Osteoporosis, Fractures, Bone
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At baseline (cross-sectional, single timepoint for data collection)
Secondary outcomes (2)
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
Measured: At baseline
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
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2017
- Study start14 Jun 2018
- Primary completionMay 2020 (estimated)
- Study completionMay 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 576 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bern
- Responsible party
- Sponsor
- Investigators
- Kurt Lippuner, M.D., Study director, Department of Osteoporosis, Bern University Hospital, University of Bern, CH-3010 Bern, SwitzerlandPhilippe Zysset, Ph.D., Study director, Institute of Surgical Technology and Biomechanics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03219099
- Sponsor's protocol ID
- UKO-2017-1
- Acronym
- NODARATIS
- Status last verified
- Oct 2018
- First submitted
- 13 Jul 2017
- Last updated
- 23 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Population-Based Normative Database for HR-pQCT-Based Distal Radius and Tibia Strength Assessment in Switzerland
- ClinicalTrials.gov ID
- NCT03219099
- Acronym / sponsor ID
- NODARATIS / UKO-2017-1
- Conditions
- Osteoporosis, Diagnoses Disease, Fracture, Bone Strength
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 576 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- University of Bern
- Study start
- 14 Jun 2018 (actual)
- Primary completion
- May 2020 (estimated)
- Study completion
- May 2020 (estimated)
- First posted
- 17 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 20 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The project population are female and male healthy volunteers above 20 years old. Following international recommendations, the number of participants for the calculation of the reference intervals is set to 576. Among these, the assessment of reproducibility of the novel bone strength estimation methodology will be performed in 42 participants.
Key inclusion criteria (2 listed)
- Healthy volunteers aged 20 years or older living in Switzerland
- Written informed consent
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
In-vivo reproducibility of radius strength calculations
Time frame: At baseline
In-vivo reproducibility of tibia strength calculations
Time frame: At baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kurt Lippuner, M.D. study director
Department of Osteoporosis, Bern University Hospital, University of Bern, CH-3010 Bern, Switzerland
Philippe Zysset, Ph.D. study director
Institute of Surgical Technology and Biomechanics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoporosis and Diagnoses Disease, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kurt Lippuner, M.D. (+41 31 632 31 28, kurt.lippuner@insel.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone strength at distal radius and tibia, assessed by HR-pQCT (time frame: At baseline (cross-sectional, single timepoint for data collection)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2018; AzTrials last refreshed its copy on 27 Oct 2026.