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

Osteoporosis Clinical Trial

— ROSA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04377880
• Other study ID #: 2019_18R
• Secondary ID: 2020-A00027-32
• Status: Recruiting
• Start date: October 15, 2020
• Est. completion date: October 2023

Study information

• Verified date: January 2023
• Source: University Hospital, Lille
• Contact: Eric FODZO, MD
• Phone: 321998835
• Email: e.fodzo[@]ch-boulogne.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: October 2023
• Est. primary completion date: October 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Osteoporosis

Locations

Country	Name	City	State
France	Centre hospitalier	Boulogne-sur-Mer

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Lille	Universite du Littoral Cote d'Opale

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Inter-subject phenotype variations by X-ray microtomography	Inter-subject phenotype variations will be related to quantitative bone microarchitecture data determined by X-ray microtomography.	Baseline