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OpenTrials
Completed

NCT Number: NCT04377880

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre hospitalier

Boulogne-sur-Mer, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Collaborators

  • Universite du Littoral Cote d'Opale

Registry information

Acronym: ROSA

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
May 6, 2020
Registry last updated
Dec 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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