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ROSA: Development of Cellular Models for Osteoblast Response Study to Adipocytic Secretions in an Osteoporosis Context.

Sponsor
University Hospital, Lille (Other)
Overall Status
Recruiting
CT.gov ID
NCT04377880
Collaborator
Universite du Littoral Cote d'Opale (Other)
20
Enrollment
1
Location
35.5
Anticipated Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The recent studies suggest that secretions from medullary adipocytes are involved in the mechanisms of bone loss in osteoporosis (OP) through their actions on neighbouring osteoforming cells, the osteoblasts. The objective of the research is the development of new cellular models representing the aging skeleton to confirm this hypothesis. To this end, osteoblasts will be isolated from human bone fragments coming from femoral heads discarded during total hip replacement surgery. The osteoblastic response to secreted factors released from medullary adipocytes of commercial origin will be analysed using conditioned media incubations. This phenotypic response will be quantified for each subject through the analysis of gene expression levels. Inter-subject phenotype variations will be related to bone density and microarchitecture data obtained by X-ray microtomography. This will assess the existence of a correlation between the osteoblast response to adipocyte secretions and the degree of osteoporosis of the subject from whom the cells are derived.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    20 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Development of Cellular Models for Osteoblast Response Study to Adipocytic Secretions in an Osteoporosis Context.
    Actual Study Start Date :
    Oct 15, 2020
    Anticipated Primary Completion Date :
    Oct 1, 2023
    Anticipated Study Completion Date :
    Oct 1, 2023

    Outcome Measures

    Primary Outcome Measures

    1. the level of gene expression of adipocyte markers such as PPARG and leptin [Baseline]

      The effect of adipocyte secretion products on osteoblasts will be evaluated by incubating osteoblasts from human bone biopsies with commercially available adipocyte conditioned cell media. Phenotypic changes in osteoblastic cells will then be evaluated by analyzing their gene expression profile and comparing them with those of osteoblasts incubated in unconditioned media. The selected criteria for judging osteoblast alteration will be the measurement of the level of gene expression of adipocyte markers such as PPARG and leptin.

    Secondary Outcome Measures

    1. Inter-subject phenotype variations by X-ray microtomography [Baseline]

      Inter-subject phenotype variations will be related to quantitative bone microarchitecture data determined by X-ray microtomography.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Adult subject

    • Surgical indication for hip prosthesis implantation

    • Affiliation to a social insurance regime

    Exclusion Criteria:

    • Rejection of participation

    • Diagnosed bone diseases other than osteoarthritis or osteoporosis

    • Cancer

    • Pregnant Women

    • Subject under guardianship or trusteeship

    • Subject unable to understand the study.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Centre hospitalier Boulogne-sur-Mer France

    Sponsors and Collaborators

    • University Hospital, Lille
    • Universite du Littoral Cote d'Opale

    Investigators

    • Principal Investigator: Eric FODZO, MD, University Hospital, Lille

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Lille
    ClinicalTrials.gov Identifier:
    NCT04377880
    Other Study ID Numbers:
    • 2019_18R
    • 2020-A00027-32
    First Posted:
    May 6, 2020
    Last Update Posted:
    May 12, 2021
    Last Verified:
    May 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Lille
    Bone
    Osteoporosis
    Osteoblast
    Adipocyte
    Cellular models
    Additional relevant MeSH terms:
    Osteoporosis

    Study Results

    No Results Posted as of May 12, 2021