Autophagy and Pathological Aging
AVP
AVP Study: Autophagy and Pathological Aging Human Study in Osteoporosis With or Without Dementia of Alzheimer's Type
1 other identifier
interventional
82
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2017
Longer than P75 for not_applicable
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 29, 2017
CompletedFirst Posted
Study publicly available on registry
June 5, 2017
CompletedStudy Start
First participant enrolled
December 20, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 20, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 20, 2021
CompletedMarch 24, 2026
March 1, 2026
3.4 years
May 29, 2017
March 20, 2026
Conditions
Keywords
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
OTHERpatient with osteoporosis and alzheimer hospitalized for total hip prosthesis.
osteoporosis without alzheimer
OTHERPatient with osteoporosis without alzheimer hospitalized for total hip prosthesis.
Patient with arthrosis without alzheimer
OTHERPatient with arthrosis without alzheimer hospitalized for total hip prosthesis.
Interventions
Quantification of autophagy (LC3II and SQSTM1 / p62) by Western blotting of purified OST proteins from a bone sample
Eligibility Criteria
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
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.
PMID: 38430550RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Veronique BREUIL, PhD
Centre Hospitalier Universitaire de Nice
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- 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