Age Influence on Cortical Bone Measured by Ultrasound

Terminated

• Conditions: Cortical Bone Erosion

• Registration Number: NCT03453242
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

The study of this study is to evaluate the age influence on cortical bone strength properties by two methods:HR-pQCT (HighResolution-peripheral quantitativeComputedTomography) and ultrasound. The main objective consists in the evaluation of the age influence on cortical thickness at 1/3 distal radius measured by US.

Detailed Description

The study of this study is to evaluate the age influence on cortical bone by two methods: HR-pQCT and ultrasound.

84 patients will be measured. The cohort will be:

* 21 women less than 70

* 21 women more than 70

* 21 men less than 70

* 21 men more than 70 Measurement will be performed at radius and at tibia (ultra-distal and distal). For all the sites one measurement will be performed by HR-pQCT to get reference values of thickness and BMDs. For the distal positions and additional measurement will be performed by an innovative ultrasound device that estimates cortical thickness and porosity.

The participation to the study implies only a participation of one hour from the patient (30min for HR-pQCT measurements, 30 min for US).

The main objectives consist in :

* evaluating the age influence on cortical thickness at 1/3 distal radius measured by US

* evaluating the age influence on cortical thickness at distal tibia measured by US

* comparing porosities values measured by US to vBMD obtained by HR-pQCT

* comparing cortical thickness values measured by HR-pQCT at 1/3 distal radius position to ultra-distal radus position and to the tibia

* comparing vBMD values measured by HRpQCT at 1/3 distal radius position to ultra-distal radius position and to the tibia

Study Timeline

• Study First Submitted: 2018-01-24
• Study First Submitted QC: 2018-02-26
• Study Start: 2018-03-02
• Study First Posted: 2018-03-05
• Primary Completion: 2019-07-19
• Study Completion: 2019-07-19
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-22
• Last Update Posted: 2021-09-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

• being 18 or older
• coming from the rheumatology consultation at Lariboisière Hospital

Exclusion Criteria

• BMI > 28
• BMI < 15
• cortisone treatment
• recent fracture at non-dominant arm
• wound on measuring zone
• treatment interfering with bone architecture or bone density : oral of transdermic oestrogenes, bisphosphonates (Alendronate, Risedronate, Zoledronate) or Denosumab during the past 6 months-

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cortical parameters measurement	Inclusion time	Cortical thickness at distal radius 1/3

Secondary Outcome Measures

Name	Time	Method
Porosity measurement	Inclusion time	Ultrasonic porosity obtained by HR-pQCT
Tibia parameters measurement by HR-pQCT	Inclusion time	Cortical thickness distal 1/2 tibia obtained by HR-pQCT; * ultra-distal and 1/3 distal cortical thicknesses obtained by HR-pQCT; * ultra-distal and 1/3 distal vBMD obtained by HR-pQCT
Cortical parameters measurement	Inclusion time	1/3 distal cortical thicknesses obtained by HR-pQCT
Tibia parameters measurement by US	Inclusion time	Cortical thickness distal 1/2 tibia obtained by US; * ultra-distal and 1/3 distal cortical thicknesses obtained by HR-pQCT; * ultra-distal and 1/3 distal vBMD obtained by HR-pQCT
Thicknesses measurement	Inclusion time	Ultra-distal thicknesses obtained by HR-pQCT
vBMD measurement	Inclusion time	vBMD obtained by HR-pQCT
Ultra-distal vBMD measurement	Inclusion time	Ultra-distal vBMD and third distal obtained by HR-pQCT

Trial Locations

Locations (1)

Cohen-Solal; 🇫🇷 Paris, Ile De France, France