Resting-state Imaging and OSteoporosiS
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Functional connectivity value of brain networks at rest
研究概览
简要总结
This study will be conducted in 20 postmenopausal healthy volunteers, 20 postmenopausal osteoporotic patients with fracture and 20 postmenopausal osteoporotic women without fracture, in order to compare functional connectivity between brain areas. Participants will complete different questionnaires and tests assessing cognition, quality of life, sleep, physical activity, pain, anxiety and depression. A biological sample will be performed in order to evaluate different markers of bone remodeling. A Resting-state functional magnetic resonance imaging (rs-fMRI) will be realized in order to establish functional connectivity between brain regions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •(patients):
- •Women aged 50 or over, with postmenopausal osteoporosis, fractured or not, diagnosed by their rheumatologist,
- •Able to give informed consent to participate in the research,
- •Affiliation with the French Social Security.
- •Inclusion Criteria (healthy volunteers):
- •Women aged 50 or over,
- •Bone densitometry performed as part of the protocol, not suggestive of osteoporosis and validated by investigators,
- •Matched to patients by age, menopausal status, socio-educational level and manual laterality,
- •Able to give informed consent to participate in the research,
- •Affiliation with the French Social Security.
- •Registration or acceptance of registration in the national register of volunteers participating in Research.
排除标准
- •(patient and healthy volunteers):
- •Presence of pacemaker,
- •Presence of medical devices (implants or prostheses),
- •Incompatibility of the patient with the safety criteria of the medical imaging center for carrying out magnetic resonance experiments at 3 Tesla,
- •Contraindications to the realization of MRI without injection such as claustrophobia proven, hearing aid, pacemaker wearers, wearing a brain clip,
- •Refusal to be informed in the event of the accidental discovery of an anomaly during the resting state functional magnetic resonance imaging,
- •Woman under legal protection or deprived of liberty,
- •Refusal to participation
研究组 & 干预措施
Postmenopausal Healthy volunteers
22 postmenopausal healthy women, matched by age, menopausal status, socio-educational level and manual laterality, will be included in this study
干预措施: Tests and questionnaires of study (Other)
Postmenopausal Healthy volunteers
22 postmenopausal healthy women, matched by age, menopausal status, socio-educational level and manual laterality, will be included in this study
干预措施: Blood sample (Other)
Postmenopausal Healthy volunteers
22 postmenopausal healthy women, matched by age, menopausal status, socio-educational level and manual laterality, will be included in this study
干预措施: Bone density exam (Other)
Postmenopausal Healthy volunteers
22 postmenopausal healthy women, matched by age, menopausal status, socio-educational level and manual laterality, will be included in this study
干预措施: Functional connectivity value of brain networks at rest (Other)
Postmenopausal osteoporotic patients with fracture
22 Postmenopausal osteoporosis patients with fractures will be included in this study
干预措施: Blood sample (Other)
Postmenopausal osteoporotic patients with fracture
22 Postmenopausal osteoporosis patients with fractures will be included in this study
干预措施: Tests and questionnaires of study (Other)
Postmenopausal osteoporotic patients with fracture
22 Postmenopausal osteoporosis patients with fractures will be included in this study
干预措施: Functional connectivity value of brain networks at rest (Other)
Postmenopausal osteoporotic patient without fracture
22 Postmenopausal osteoporosis patients without fractures will be included in this study.
干预措施: Blood sample (Other)
Postmenopausal osteoporotic patient without fracture
22 Postmenopausal osteoporosis patients without fractures will be included in this study.
干预措施: Tests and questionnaires of study (Other)
Postmenopausal osteoporotic patient without fracture
22 Postmenopausal osteoporosis patients without fractures will be included in this study.
干预措施: Functional connectivity value of brain networks at rest (Other)
结局指标
主要结局
Functional connectivity value of brain networks at rest
时间窗: At visit 2 (end of study visit, up to fifteen days after inclusion) for osteoporotic patient group and at visit 3 (end of study visit, up to one month after inclusion) for healthy volunteers group.
The primary outcome is the functional connectivity value of brain networks at rest, calculated from resting-state fMRI data.
次要结局
- Evaluation of cognitive function (MoCA test)(At inclusion visit (Day 0) for osteoporotic patient group and at visit 2 (up to fifteen days after inclusion) for healthy volunteers group.)
- Evaluation of cognitive function (Cantab test: MOT)(At inclusion visit (Day 0) for osteoporotic patient group and at visit 2 (up to fifteen days after inclusion) for healthy volunteers group.)
- Evaluation of cognitive function (CANTAB test: Reaction Time (RTI)(At inclusion visit (Day 0) for osteoporotic patient group and at visit 2 (up to fifteen days after inclusion) for healthy volunteers group.)
- Osteocalcin dosage(At inclusion visit (Day 0) for osteoporotic patient group and at visit 2 (up to fifteen days after inclusion) for healthy volunteers group.)
- Evaluation of cognitive function (CANTAB test: Digit Span)(At inclusion visit (Day 0) for osteoporotic patient group and at visit 2 (up to fifteen days after inclusion) for healthy volunteers group.)
- Evaluation of cognitive function (CANTAB test: Match to Sample Visual Search)(At inclusion visit (Day 0) for osteoporotic patient group and at visit 2 (up to fifteen days after inclusion) for healthy volunteers group.)
- Evaluation of cognitive function (Trail Making Test)(At inclusion visit (Day 0) for osteoporotic patient group and at visit 2 (up to fifteen days after inclusion) for healthy volunteers group.)
- Evaluation of cognitive function (Stroop test)(At inclusion visit (Day 0) for osteoporotic patient group and at visit 2 (up to fifteen days after inclusion) for healthy volunteers group.)
- Evaluation of cognitive function (Verbal fluency test)(At inclusion visit (Day 0) for osteoporotic patient group and at visit 2 (up to fifteen days after inclusion) for healthy volunteers group.)
- Evaluation of cognitive function (5 words test)(At inclusion visit (Day 0) for osteoporotic patient group and at visit 2 (up to fifteen days after inclusion) for healthy volunteers group.)
- Periostin dosage(At inclusion visit (Day 0) for osteoporotic patient group and at visit 2 (up to fifteen days after inclusion) for healthy volunteers group.)
- Evaluation of cognitive function (Oral Picture Naming Test)(At inclusion visit (Day 0) for osteoporotic patient group and at visit 2 (up to fifteen days after inclusion) for healthy volunteers group.)
- The Pittsburgh Sleep Quality Index (PSQI)(At inclusion visit (Day 0) for osteoporotic patient group and at visit 2 (up to fifteen days after inclusion) for healthy volunteers group.)
- Evaluation of pain: The Brief Pain Inventory Questionnaire (BPI)(At inclusion visit (Day 0) for osteoporotic patient group and at visit 2 (up to fifteen days after inclusion) for healthy volunteers group.)
- Evaluation of pain: Numerical pain scale(At inclusion visit (Day 0) for osteoporotic patient group and at visit 2 (up to fifteen days after inclusion) for healthy volunteers group.)
- Evaluation of quality of life: The 36-Item Short Form Survey (SF-36)(At inclusion visit (Day 0) for osteoporotic patient group and at visit 2 (up to fifteen days after inclusion) for healthy volunteers group.)
- Evaluation of anxiety and depression: The Hospital Anxiety and Depression Scale (HAD)(At inclusion visit (Day 0) for osteoporotic patient group and at visit 2 (up to fifteen days after inclusion) for healthy volunteers group.)
- Evaluation of physical activity: International Physical Activity Questionnaire - Short Form(At inclusion visit (Day 0) for osteoporotic patient group and at visit 2 (up to fifteen days after inclusion) for healthy volunteers group.)
- Sclerostin dosage(At inclusion visit (Day 0) for osteoporotic patient group and at visit 2 (up to fifteen days after inclusion) for healthy volunteers group.)
- Irisin dosage(At inclusion visit (Day 0) for osteoporotic patient group and at visit 2 (up to fifteen days after inclusion) for healthy volunteers group.)
- N-terminal propeptide of procollagen type 1 dosage(At inclusion visit (Day 0) for osteoporotic patient group and at visit 2 (up to fifteen days after inclusion) for healthy volunteers group.)
- Dickkopf-related protein 1 dosage(At inclusion visit (Day 0) for osteoporotic patient group and at visit 2 (up to fifteen days after inclusion) for healthy volunteers group.)
- C-terminal telopeptides of collagen type 1 dosage(At inclusion visit (Day 0) for osteoporotic patient group and at visit 2 (up to fifteen days after inclusion) for healthy volunteers group.)