Age Influence on Cortical Bone Measured by Ultrasound (OCO-US)

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.

Study Overview

• Status: Terminated
• Conditions: Cortical Bone Erosion
• Intervention / Treatment: Other: Bone measurement by HR-pQCT and ultrasound

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 Type: Observational
• Enrollment (Actual): 66

Contacts and Locations

Study Locations

• France
  • Ile De France
    • Paris, Ile De France, France, 75010
      • Cohen-Solal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The cohort will be:

Women and men less than 70 Women and men more than 70

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cortical parameters measurement	Cortical thickness at distal radius 1/3	Inclusion time

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tibia parameters measurement by US	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	Inclusion time
Tibia parameters measurement by HR-pQCT	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	Inclusion time
Porosity measurement	Ultrasonic porosity obtained by HR-pQCT	Inclusion time
vBMD measurement	vBMD obtained by HR-pQCT	Inclusion time
Cortical parameters measurement	1/3 distal cortical thicknesses obtained by HR-pQCT	Inclusion time
Thicknesses measurement	Ultra-distal thicknesses obtained by HR-pQCT	Inclusion time
Ultra-distal vBMD measurement	Ultra-distal vBMD and third distal obtained by HR-pQCT	Inclusion time

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Cohen-Solal Martine, Martine, APHP

Publications and helpful links

General Publications

• Barkmann R, Kantorovich E, Singal C, Hans D, Genant HK, Heller M, Gluer CC. A new method for quantitative ultrasound measurements at multiple skeletal sites: first results of precision and fracture discrimination. J Clin Densitom. 2000 Spring;3(1):1-7. doi: 10.1385/jcd:3:1:001.
• Bochud N, Vallet Q, Bala Y, Follet H, Minonzio JG, Laugier P. Genetic algorithms-based inversion of multimode guided waves for cortical bone characterization. Phys Med Biol. 2016 Oct 7;61(19):6953-6974. doi: 10.1088/0031-9155/61/19/6953. Epub 2016 Sep 12.
• Zebaze RM, Ghasem-Zadeh A, Bohte A, Iuliano-Burns S, Mirams M, Price RI, Mackie EJ, Seeman E. Intracortical remodelling and porosity in the distal radius and post-mortem femurs of women: a cross-sectional study. Lancet. 2010 May 15;375(9727):1729-36. doi: 10.1016/S0140-6736(10)60320-0.

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2018
• Primary Completion (Actual): July 19, 2019
• Study Completion (Actual): July 19, 2019

Study Registration Dates

• First Submitted: January 24, 2018
• First Submitted That Met QC Criteria: February 26, 2018
• First Posted (Actual): March 5, 2018

Study Record Updates

• Last Update Posted (Actual): September 27, 2021
• Last Update Submitted That Met QC Criteria: September 22, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Osteoporosis
• Other Study ID Numbers: K 171006J

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

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