Clinical trial NCT03453242: Age Influence on Cortical Bone Measured by Ultrasound
Official title: Age Influence on Cortical Bone Measured by Ultrasound
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Cortical Bone Erosion
Keywords: Osteoporosis
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2018-03-05
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The cohort will be:

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

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

Eligibility criteria: 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-

Primary outcomes:
measure: Cortical parameters measurement
timeFrame: Inclusion time
Secondary outcomes:
measure: Tibia parameters measurement by US
timeFrame: Inclusion time
measure: Tibia parameters measurement by HR-pQCT
timeFrame: Inclusion time
measure: Porosity measurement
timeFrame: Inclusion time
measure: vBMD measurement
timeFrame: Inclusion time
measure: Cortical parameters measurement
timeFrame: Inclusion time
measure: Thicknesses measurement
timeFrame: Inclusion time
measure: Ultra-distal vBMD measurement
timeFrame: Inclusion time
Other outcomes:
Locations:
city: Paris
country: France
facility: Cohen-Solal
state: Ile De France
Study officials:
affiliation: APHP
name: Cohen-Solal Martine, Martine
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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. doi: 10.1088/0031-9155/61/19/6953. Epub 2016 Sep 12.
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.