Development of Cellular Models for Osteoblast Response Study to Adipocytic Secretions in an Osteoporosis Context.
ROSA
2 other identifiers
observational
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Oct 2020
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 5, 2020
CompletedFirst Posted
Study publicly available on registry
May 6, 2020
CompletedStudy Start
First participant enrolled
October 15, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 4, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 4, 2024
CompletedDecember 23, 2025
December 1, 2025
3.9 years
May 5, 2020
December 17, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
the level of gene expression of adipocyte markers such as PPARG and leptin
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 Outcomes (1)
Inter-subject phenotype variations by X-ray microtomography
Baseline
Eligibility Criteria
Patients with a surgical indication for a prosthetic hip joint at the Boulogne-sur-Mer hospital.
You may qualify if:
- Adult subject
- Surgical indication for hip prosthesis implantation
- Affiliation to a social insurance regime
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Lillelead
- Universite du Littoral Cote d'Opalecollaborator
Study Sites (1)
Centre hospitalier
Boulogne-sur-Mer, France
Biospecimen
Bone fragments; RNA
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eric FODZO, MD
University Hospital, Lille
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 5, 2020
First Posted
May 6, 2020
Study Start
October 15, 2020
Primary Completion
September 4, 2024
Study Completion
September 4, 2024
Last Updated
December 23, 2025
Record last verified: 2025-12