Normative Database for HR-pQCT-Based Radius and Tibia Strength (NODARATIS)

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.

Study Overview

• Status: Unknown
• Conditions: 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.

• Study Type: Observational
• Enrollment (Anticipated): 576

Contacts and Locations

• Study Contact: Name: Kurt Lippuner, M.D.; Phone Number: +41 31 632 31 28; Email: kurt.lippuner@insel.ch
• Study Contact Backup: Name: Anna Stuck, M.D.; Phone Number: +41 31 632 69 41; Email: anna.stuck@insel.ch

Study Locations

• Switzerland
  • Bern, Switzerland, 3010
    • Recruiting
    • University Hospital Inselspital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 100 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: University Hospital Inselspital, Berne
• Collaborators: University of Bern
• Investigators: 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

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 14, 2018
• Primary Completion (ANTICIPATED): May 1, 2020
• Study Completion (ANTICIPATED): May 1, 2020

Study Registration Dates

• First Submitted: July 13, 2017
• First Submitted That Met QC Criteria: July 13, 2017
• First Posted (ACTUAL): July 17, 2017

Study Record Updates

• Last Update Posted (ACTUAL): October 23, 2018
• Last Update Submitted That Met QC Criteria: October 20, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Osteoporosis
• Other Study ID Numbers: UKO-2017-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No