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Trial record 83 of 10381 for:    strength

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
Sponsor:
Collaborator:
University of Bern
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

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.


Condition or disease
Osteoporosis Diagnoses Disease Fracture Bone Strength

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.


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Study Type : Observational
Estimated Enrollment : 576 participants
Observational Model: Other
Time Perspective: Cross-Sectional
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



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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



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Ages Eligible for Study:   20 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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.
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Kurt Lippuner, M.D. +41 31 632 31 28 kurt.lippuner@insel.ch
Contact: Anna Stuck, M.D. +41 31 632 69 41 anna.stuck@insel.ch

Locations
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Switzerland
University Hospital Inselspital Recruiting
Bern, Switzerland, 3010
Sponsors and Collaborators
University Hospital Inselspital, Berne
University of Bern
Investigators
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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

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Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT03219099     History of Changes
Other Study ID Numbers: UKO-2017-1
First Posted: July 17, 2017    Key Record Dates
Last Update Posted: October 23, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases