NCT04377880

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 6, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

October 15, 2020

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 4, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 4, 2024

Completed
Last Updated

December 23, 2025

Status Verified

December 1, 2025

Enrollment Period

3.9 years

First QC Date

May 5, 2020

Last Update Submit

December 17, 2025

Conditions

Keywords

BoneOsteoporosisOsteoblastAdipocyteCellular models

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

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

Study Sites (1)

Centre hospitalier

Boulogne-sur-Mer, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

Bone fragments; RNA

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Eric FODZO, MD

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR

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

Locations