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TerminatedNCT03453242OCO-USUpdated Sep 27, 2021

Age Influence on Cortical Bone Measured by Ultrasound

An observational study in Cortical Bone Erosion, sponsored by Assistance Publique - Hôpitaux de Paris. Terminated at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-09-27.

Sponsored by Assistance Publique - Hôpitaux de Paris · Observational

Why this study was terminated
Difficulty of recruitment due to COVID-19
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
66
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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
02

Conditions studied

  • Cortical Bone Erosion

Keywords

  • Osteoporosis
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The cohort will be:

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

Inclusion criteria

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

Exclusion criteria

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-
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
66 participants (actual)
Target follow-up
1 Day
Patient registry
Yes

Interventions

  • OtherBone 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.

05

What researchers measure

Primary outcomes

  1. Cortical parameters measurement

    Cortical thickness at distal radius 1/3

    Time frame: Inclusion time

Secondary outcomes

  1. 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

    Time frame: Inclusion time

  2. 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

    Time frame: Inclusion time

  3. Porosity measurement

    Ultrasonic porosity obtained by HR-pQCT

    Time frame: Inclusion time

  4. vBMD measurement

    vBMD obtained by HR-pQCT

    Time frame: Inclusion time

  5. Cortical parameters measurement

    1/3 distal cortical thicknesses obtained by HR-pQCT

    Time frame: Inclusion time

  6. Thicknesses measurement

    Ultra-distal thicknesses obtained by HR-pQCT

    Time frame: Inclusion time

  7. Ultra-distal vBMD measurement

    Ultra-distal vBMD and third distal obtained by HR-pQCT

    Time frame: Inclusion time

06

Study locations

1 site
  • Cohen-Solal
    Paris, Ile De France 75010, France
07

References and documents

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. PubMed 10745297 ↗
  • 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. PubMed 27617648 ↗
  • 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. PubMed 20472174 ↗

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT03453242
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Responsible party
Sponsor
First posted
Mar 5, 2018
Start date
Mar 2, 2018
Primary completion
Jul 19, 2019
Completion
Jul 19, 2019
Last update
Sep 27, 2021

Study contacts

Cohen-Solal Martine, Martine
principal investigator · APHP

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

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