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

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ClinicalTrials.gov Identifier: NCT03453242
Recruitment Status : Recruiting
First Posted : March 5, 2018
Last Update Posted : March 25, 2019
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Study Description
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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.

Condition or disease Intervention/treatment
Cortical Bone Erosion 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 Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 84 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Day
Official Title: Age Influence on Cortical Bone Measured by Ultrasound
Actual Study Start Date : March 2, 2018
Estimated Primary Completion Date : March 2, 2020
Estimated Study Completion Date : March 2, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Groups and Cohorts
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Intervention Details:
  • 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.

Outcome Measures
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Primary Outcome Measures :
  1. Cortical parameters measurement [ Time Frame: Inclusion time ]
    Cortical thickness at distal radius 1/3


Secondary Outcome Measures :
  1. Tibia parameters measurement by US [ Time Frame: 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

  2. Tibia parameters measurement by HR-pQCT [ Time Frame: 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

  3. Porosity measurement [ Time Frame: Inclusion time ]
    Ultrasonic porosity obtained by HR-pQCT

  4. vBMD measurement [ Time Frame: Inclusion time ]
    vBMD obtained by HR-pQCT

  5. Cortical parameters measurement [ Time Frame: Inclusion time ]
    1/3 distal cortical thicknesses obtained by HR-pQCT

  6. Thicknesses measurement [ Time Frame: Inclusion time ]
    Ultra-distal thicknesses obtained by HR-pQCT

  7. Ultra-distal vBMD measurement [ Time Frame: Inclusion time ]
    Ultra-distal vBMD and third distal obtained by HR-pQCT


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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

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-
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03453242


Contacts
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Contact: Cohen-Solal Martine, PhD +33149956358 Martine.cohen-solal@inserm.fr
Contact: MINONZIO Jean-Gabriel, PhD +33144414971 jean-gabriel.minonzio@upmc.fr

Locations
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France
Cohen-Solal Recruiting
Paris, Ile De France, France, 75010
Contact: Martine COHEN-SOLAL, PhD    0149956358 ext +33    martine.cohen-solal@inserm.fr   
Contact: Jean-Gabriel MINONZIO, PhD    0144414971 ext +33    jean-gabriel.minonzio@upmc.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Cohen-Solal Martine, Martine APHP
More Information
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Additional Information:

Publications:

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03453242     History of Changes
Other Study ID Numbers: K 171006J
First Posted: March 5, 2018    Key Record Dates
Last Update Posted: March 25, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Osteoporosis