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

January 17, 2023 updated by: University Hospital, Lille
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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Boulogne-sur-Mer, France
        • Recruiting
        • Centre Hospitalier
        • Principal Investigator:
          • Eric FODZO, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with a surgical indication for a prosthetic hip joint at the Boulogne-sur-Mer hospital.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the level of gene expression of adipocyte markers such as PPARG and leptin
Time Frame: 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.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inter-subject phenotype variations by X-ray microtomography
Time Frame: Baseline
Inter-subject phenotype variations will be related to quantitative bone microarchitecture data determined by X-ray microtomography.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Lille

Collaborators

Universite du Littoral Cote d'Opale

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 15, 2020

Primary Completion (Anticipated)

October 1, 2023

Study Completion (Anticipated)

October 1, 2023

Study Registration Dates

First Submitted

May 5, 2020

First Submitted That Met QC Criteria

May 5, 2020

First Posted (Actual)

May 6, 2020

Study Record Updates

Last Update Posted (Actual)

January 18, 2023

Last Update Submitted That Met QC Criteria

January 17, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019_18R
  • 2020-A00027-32 (Other Identifier: ID-RCB number,ANSM)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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