Normative Database for HR-pQCT-Based Radius and Tibia Strength

NCT03219099 | Unknown

• 1 other identifier: UKO-2017-1
• Study Type: observational
• Target: 576
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoporosis; Diagnoses Disease; Fracture; Bone Strength

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• In-vivo reproducibility of radius strength calculations

  At baseline

• In-vivo reproducibility of tibia strength calculations

  At baseline

Eligibility Criteria

• Age: 20 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Healthy volunteers aged 20 years or older living in Switzerland
• Written informed consent

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead
• University of Bern: collaborator

Study Sites (1)

University Hospital Inselspital

Bern, 3010, Switzerland

RECRUITING

MeSH Terms

Conditions

Osteoporosis; Fractures, Bone

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Wounds and Injuries

Study Officials

• 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 DIRECTOR

Central Study Contacts

Kurt Lippuner, M.D.

CONTACT

+41 31 632 31 28; kurt.lippuner@insel.ch

Anna Stuck, M.D.

CONTACT

+41 31 632 69 41; anna.stuck@insel.ch

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2017
• First Posted: July 17, 2017
• Study Start: June 14, 2018
• Primary Completion: May 1, 2020
• Study Completion: May 1, 2020
• Last Updated: October 23, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)