NCT03175874

Brief Summary

Autophagy is recognized as a central mechanism for the regulation of aging. . Osteoporosis (OA) and Alzheimer's disease (AD) are two forms of pathological aging, sometimes entangled, including an over-risk of OP in AD and degradation of cognitive functions after OP fracture, but the link between These two pathologies remain poorly understood. The aim of this prospective pilot study is to evaluate the level of autophagy of osteocytes (OST) in postmenopausal women with OP and to explore the hypothesis that the defect of autophagy is one of the physiopathological links of the OP During the MA

Trial Health

87
On Track

Trial Health Score

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

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2017

Longer than P75 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 29, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 5, 2017

Completed
7 months until next milestone

Study Start

First participant enrolled

December 20, 2017

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2021

Completed
Last Updated

March 24, 2026

Status Verified

March 1, 2026

Enrollment Period

3.4 years

First QC Date

May 29, 2017

Last Update Submit

March 20, 2026

Conditions

Keywords

OsteoporosisAlzheimer Disease

Outcome Measures

Primary Outcomes (1)

  • Quantification of autophagy

    Quantification of autophagy (LC3II and SQSTM1 / p62) by Western blotting of purified OST proteins from a bone sample from resected femoral heads

    at inclusion

Secondary Outcomes (2)

  • Bone mineral density

    at inclusion

  • 25 OH vitamin D (ng/ml).

    at inclusion

Study Arms (3)

osteoporosis and alzheimer

OTHER

patient with osteoporosis and alzheimer hospitalized for total hip prosthesis.

Procedure: Hip bone sampling

osteoporosis without alzheimer

OTHER

Patient with osteoporosis without alzheimer hospitalized for total hip prosthesis.

Procedure: Hip bone sampling

Patient with arthrosis without alzheimer

OTHER

Patient with arthrosis without alzheimer hospitalized for total hip prosthesis.

Procedure: Hip bone sampling

Interventions

Quantification of autophagy (LC3II and SQSTM1 / p62) by Western blotting of purified OST proteins from a bone sample

Patient with arthrosis without alzheimerosteoporosis and alzheimerosteoporosis without alzheimer

Eligibility Criteria

Age65 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Women \> 65 y: 2 groups
  • Osteoporotic femoral neck fracture requiring hip remplacement and fullfilling WHO definition of osteoporosis. Without any cognitive impairment for the first subgroup (MMSE \> 26 and normal IADL) and with a final diagnosis of alzheimer disease in the other subgroup (DSM-IV-TR)
  • Non osteoporotic (no fragility fracture (clinical or on VFA) and bone mineral density T-score \> 2.5 SD at all sites)
  • No cognitive impairment (MMSE \> 26 and normal IADL)

You may not qualify if:

  • Other pathologies associated with autophagy: Parkinson's disease, Crohn's disease, cancers, myopathies, type 2 diabetes
  • Méd Medications interfering with autophagy: current corticosteroids, parathyroid hormone, estrogen, chloroquine, hydroxychloroquine, lithium, metformin, bisphosphonates,
  • Dementia of non-Alzheimer type

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BREUIL

Nice, 06000, France

Location

Related Publications (1)

  • Trojani MC, Clave A, Bereder I, Camuzard O, Bernard De Dompsure R, Gonzalez JF, Trojani C, Santucci-Darmanin S, Carle GF, Breuil V, Pierrefite-Carle V. Autophagy markers are decreased in bone of osteoporotic patients: a monocentric comparative study. Eur J Endocrinol. 2024 Mar 2;190(3):K27-K31. doi: 10.1093/ejendo/lvae017.

MeSH Terms

Conditions

OsteoporosisAlzheimer Disease

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesDementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Veronique BREUIL, PhD

    Centre Hospitalier Universitaire de Nice

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: Quantification of autophagy (LC3II and SQSTM1 / p62) by Western blotting of purified OST proteins from a bone sample from resected femoral heads during laying of a total hip prosthesis.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 29, 2017

First Posted

June 5, 2017

Study Start

December 20, 2017

Primary Completion

May 20, 2021

Study Completion

May 20, 2021

Last Updated

March 24, 2026

Record last verified: 2026-03

Locations