Ignite Creation Date:
2024-05-06 @ 10:08 AM
Last Modification Date:
2024-10-26 @ 12:25 PM
Study NCT ID:
NCT03175874
Status:
COMPLETED
Last Update Posted:
2023-11-18
First Post:
2017-05-29
Brief Title:
Autophagy and Pathological Aging
Sponsor:
Centre Hospitalier Universitaire de Nice
Organization:
Centre Hospitalier Universitaire de Nice
Study Overview
Official Title:
AVP Study Autophagy and Pathological Aging Human Study in Osteoporosis With or Without Dementia of Alzheimers Type
Status:
COMPLETED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AVP
Brief Summary:
Autophagy is recognized as a central mechanism for the regulation of aging Osteoporosis OA and Alzheimers 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
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 Alzheimers 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 Alzheimers 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 Alzheimers 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
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 Alzheimers 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None