OsteoporosisAVPNCT03175874
Autophagy and Pathological Aging
A study testing Hip bone sampling in people with Osteoporosis, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and older, women only
- Conditions the study is for
- Osteoporosis
- What is being tested?
- Hip bone sampling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteFrance
- Study dates
- 20 Dec 2017to 20 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- Women only
- No healthy volunteers
- Older adult
Who may be able to join
- Women > 65 y: 2 groups
- Inclusion criteria for Osteoporosis group (Alzheimer and non-Alzheimer):
- 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)
Who cannot join
- Non-Inclusion Criteria for both groups:
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: AVP Study: Autophagy and Pathological Aging Human Study in Osteoporosis With or Without Dementia of Alzheimer's Type
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
Read the detailed description
Autophagy is a ubiquitous cellular mechanism that degrades and recycles toxic waste from cells. It 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. In Alzheimer's disease (AD), a deficiency of autophagy is found both clinically and fundamentally. In animal studies, animal studies have shown that autophagy is involved in the differentiation, function and survival of bone cells, decreases with age and that a defect in autophagy is accompanied by a decrease in The bone mass. To date, we do not have human data on the autophagic capacities of bone cells in OP and AD.
The aim of this prospective pilot study is to evaluate the level of autophagy of osteocytes (OST) in postmenopausal women with OP and to investigate the hypothesis that the defect of autophagy is one of the physiopathological links of the OP During the MA.
The main objective is to determine, in two subgroups with or without Alzheimer's disease, whether there is an association between bone status and the level of autophagy of OST in postmenopausal women (OP versus non-OP)
Secondary objectives are to determine whether there is an association between the level of autophagy of the OST and the bone parameters (bone mineral density, serum vitamin D) and to compare in OP women the level of autophagy of the OST Of AM patients vs no MA.
Study population: Postmenopausal women over the age of 65 benefiting from the implantation of a hip prosthesis: 30 with an OP fracture of the femoral neck (15 non-MA and 15 MA, the cognitive status being determined by MMSE And IADL 1 month after the fracture) and 30 controls performed for osteoarthritis, free from OP (antecedents + bone mineral density) and MA (MMSE and IADL).
Primary endpoint: 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 prosthesis Of hip.
Secondary endpoints: Bone mineral density of femoral neck and total hip (T-score and g / cm²) measured by X-ray biphotonic absorptiometry (Hologic QDR 4500) and serum 25 OH vitamin D (ng / ml).
Expected benefits: to better understand the role of autophagy in the pathophysiology of post-menopausal OP and AD in human pathology. Ultimately, it could potentially contribute to the design of new therapeutics targeting autophagy in the management of osteoporosis and more generally pathological aging.
- Conditions
- Osteoporosis
- Being tested
- Hip bone sampling
- Keywords
- Osteoporosis, Alzheimer Disease
- Medical subject headings
- Osteoporosis, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hip bone samplingProcedure or surgery
Quantification of autophagy (LC3II and SQSTM1 / p62) by Western blotting of purified OST proteins from a bone sample
| Study group | Role | What they receive |
|---|---|---|
| osteoporosis and alzheimer | Other | patient with osteoporosis and alzheimer hospitalized for total hip prosthesis. Receives: Procedure: Hip bone sampling |
| osteoporosis without alzheimer | Other | Patient with osteoporosis without alzheimer hospitalized for total hip prosthesis. Receives: Procedure: Hip bone sampling |
| Patient with arthrosis without alzheimer | Other | Patient with arthrosis without alzheimer hospitalized for total hip prosthesis. Receives: Procedure: Hip bone sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at inclusion
Secondary outcomes (2)
Bone mineral density
Bone mineral density of femoral neck and total hip (T-score and g / cm²) as measured by X-ray biphotonic absorptiometry (Hologic QDR 4500)
Measured: at inclusion
25 OH vitamin D (ng/ml).
25 OH vitamin D (ng/ml) in serum
Measured: at inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2017
- Study start20 Dec 2017
- Primary completion20 May 2021
- Study completion20 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Veronique BREUIL, PhD, Principal investigator, Centre Hospitalier Universitaire de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03175874
- Sponsor's protocol ID
- 17-PP-03
- Acronym
- AVP
- Status last verified
- Mar 2026
- First submitted
- 29 May 2017
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 38430550
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AVP Study: Autophagy and Pathological Aging Human Study in Osteoporosis With or Without Dementia of Alzheimer's Type
- ClinicalTrials.gov ID
- NCT03175874
- Acronym / sponsor ID
- AVP / 17-PP-03
- Conditions
- Osteoporosis
- Keywords
- Osteoporosis, Alzheimer Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 20 Dec 2017 (actual)
- Primary completion
- 20 May 2021 (actual)
- Study completion
- 20 May 2021 (actual)
- First posted
- 5 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Autophagy is a ubiquitous cellular mechanism that degrades and recycles toxic waste from cells. It 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. In Alzheimer's disease (AD), a deficiency of autophagy is found both clinically and fundamentally. In animal studies, animal studies have shown that autophagy is involved in the differentiation, function and survival of bone cells, decreases with age and that a defect in autophagy is accompanied by a decrease in The bone mass. To date, we do not have human data on the autophagic capacities of bone cells in OP and AD.
The aim of this prospective pilot study is to evaluate the level of autophagy of osteocytes (OST) in postmenopausal women with OP and to investigate the hypothesis that the defect of autophagy is one of the physiopathological links of the OP During the MA.
The main objective is to determine, in two subgroups with or without Alzheimer's disease, whether there is an association between bone status and the level of autophagy of OST in postmenopausal women (OP versus non-OP)
Secondary objectives are to determine whether there is an association between the level of autophagy of the OST and the bone parameters (bone mineral density, serum vitamin D) and to compare in OP women the level of autophagy of the OST Of AM patients vs no MA.
Study population: Postmenopausal women over the age of 65 benefiting from the implantation of a hip prosthesis: 30 with an OP fracture of the femoral neck (15 non-MA and 15 MA, the cognitive status being determined by MMSE And IADL 1 month after the fracture) and 30 controls performed for osteoarthritis, free from OP (antecedents + bone mineral density) and MA (MMSE and IADL).
Primary endpoint: 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 prosthesis Of hip.
Secondary endpoints: Bone mineral density of femoral neck and total hip (T-score and g / cm²) measured by X-ray biphotonic absorptiometry (Hologic QDR 4500) and serum 25 OH vitamin D (ng / ml).
Expected benefits: to better understand the role of autophagy in the pathophysiology of post-menopausal OP and AD in human pathology. Ultimately, it could potentially contribute to the design of new therapeutics targeting autophagy in the management of osteoporosis and more generally pathological aging.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| osteoporosis and alzheimer | Other | Procedure: Hip bone samplingpatient with osteoporosis and alzheimer hospitalized for total hip prosthesis. |
| osteoporosis without alzheimer | Other | Procedure: Hip bone samplingPatient with osteoporosis without alzheimer hospitalized for total hip prosthesis. |
| Patient with arthrosis without alzheimer | Other | Procedure: Hip bone samplingPatient with arthrosis without alzheimer hospitalized for total hip prosthesis. |
Who may qualify
- Ages
- 65 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hip bone samplingQuantification of autophagy (LC3II and SQSTM1 / p62) by Western blotting of purified OST proteins from a bone sample | Procedure or surgery | Patient with arthrosis without alzheimer, osteoporosis and alzheimer, osteoporosis without alzheimer |
Primary outcome
Quantification of autophagy
Time frame: at inclusion
Quantification of autophagy (LC3II and SQSTM1 / p62) by Western blotting of purified OST proteins from a bone sample from resected femoral heads
2 secondary outcomes
Bone mineral density
Time frame: at inclusion
25 OH vitamin D (ng/ml).
Time frame: at inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
- Results publication: PubMed 38430550Trojani 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Veronique BREUIL, PhD principal investigator
Centre Hospitalier Universitaire de Nice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hip bone sampling in people with Osteoporosis, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantification of autophagy (time frame: at inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03175874, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2026.