Age Influence on Cortical Bone Measured by Ultrasound

Cortical Bone Erosion Clinical Trial

— OCO-US  

Official title:

Age Influence on Cortical Bone Measured by Ultrasound

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03453242
• Other study ID #: K 171006J
• Status: Terminated
• Start date: March 2, 2018
• Est. completion date: July 19, 2019

Study information

• Verified date: September 2021
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 66
• Est. completion date: July 19, 2019
• Est. primary completion date: July 19, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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-

Related Conditions & MeSH terms

• Cortical Bone Erosion

Intervention

Other:
• Bone measurement by HR-pQCT and ultrasound
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.

Locations

Country	Name	City	State
France	Cohen-Solal	Paris	Ile De France

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (3)

Barkmann R, Kantorovich E, Singal C, Hans D, Genant HK, Heller M, Glüer 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. — View Citation

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. Epub 2016 Sep 12. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cortical parameters measurement	Cortical thickness at distal radius 1/3	Inclusion time
Secondary	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
Secondary	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
Secondary	Porosity measurement	Ultrasonic porosity obtained by HR-pQCT	Inclusion time
Secondary	vBMD measurement	vBMD obtained by HR-pQCT	Inclusion time
Secondary	Cortical parameters measurement	1/3 distal cortical thicknesses obtained by HR-pQCT	Inclusion time
Secondary	Thicknesses measurement	Ultra-distal thicknesses obtained by HR-pQCT	Inclusion time
Secondary	Ultra-distal vBMD measurement	Ultra-distal vBMD and third distal obtained by HR-pQCT	Inclusion time