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临床试验/NCT03175874
NCT03175874已完成不适用

AVP Study: Autophagy and Pathological Aging Human Study in Osteoporosis With or Without Dementia of Alzheimer's Type

Centre Hospitalier Universitaire de Nice1 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2017年12月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
82
试验地点
1
主要终点
Quantification of autophagy

研究概览

简要总结

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

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Inclusion criteria for both groups:
  • 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)
  • Inclusion criteria for Control group:
  • 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)

排除标准

  • 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

结局指标

主要结局

Quantification of autophagy

时间窗: at inclusion

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

次要结局

  • Bone mineral density(at inclusion)
  • 25 OH vitamin D (ng/ml).(at inclusion)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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