Study on Vascular Function, Sarcopenia and Pain in Treated Postmenopausal Osteoporosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Endothelial dysfunction measured by FMD (Flow-Mediated Dilation) in patients with anti-osteoporotic treatment
研究概览
简要总结
This study aims to follow a cohort of osteoporotic patients treated with anti-osteoporotic drugs and to evaluate the impact of these treatments on the osteoporosis-cardiovascular-sarcopenia triad and on pain.
详细描述
Exploratory study involving functional explorations in longitudinal follow-up, initiated in parallel with a treatment indicated in the patient's usual care and management.
The main objective is the evaluation of the evolution of the vascular and endothelial function.
The secondary objectives are:
- To study the evolution of cardiovascular parameters,
- To study the evolution of sarcopenia,
- To study the evolution of quality of life and pain,
- To study the evolution of bone remodeling (by creating a collection of biological samples),
- To study the genetic predisposition of osteoporosis including the confirmation of known genetic markers and the potential identification of new genetic variants involved (by creating a biobank),
- To study epigenetic biomarkers in the osteoporosis patient population (by creating a biobank),
- To study the role of the microbiota in osteoporosis patients (by creating a biobank),
- To study the determinants of the evolution of the studied parameters and to identify trajectories (therapeutic response profiles).
As part of their usual care and management, patients will be diagnosed with osteoporosis and prescribed anti-osteoporotic drugs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- 否
入选标准
- •Women aged 50 years or older with postmenopausal osteoporosis, whether fractured or not, requiring initiation of treatment with antiosteoporotic drugs (bisphosphonates, raloxifene, teriparatide, denosumab and others to come for this indication, including romosozumab), either orally or by injection, as part of their care and management.
- •Able to give informed consent to participate in research.
- •Affiliation to a Social Security system.
排除标准
- •Patient with chronic renal failure, defined as glomerular filtration rate < 30 mL.min-1 estimated by CKD-EPI.
- •Patient with a medical and/or surgical history deemed by the investigator or his/her representative to be incompatible with the trial.
- •Patient under legal protection or deprived of liberty.
- •Refusal to participate.
研究组 & 干预措施
Cohort follow-up
Exploratory study involving functional explorations in longitudinal follow-up, initiated in parallel with a treatment indicated in the patient's usual care and management.
干预措施: Cohort follow-up (Other)
结局指标
主要结局
Endothelial dysfunction measured by FMD (Flow-Mediated Dilation) in patients with anti-osteoporotic treatment
时间窗: Visit 5: Day 0+4 years
FMD is a non-invasive technique. It was assessed using an ultrasound approach with a high-resolution linear array transducer coupled with computer-assisted analysis software. With this software, changes in the brachial artery could be assessed in real-time through an automated edge detection system. Longitudinal images of the brachial artery were obtained with the transducer fixed on the medial aspect of the dominant arm, approximately 2 cm above the medial epicondyle of the humerus. The transducer was fixed on the arm by a special arm-holding device. The brachial artery diameter was acquired as per a 30 s baseline measure, after which a cuff was placed around forearm (3 cm above wrist) and inflated to 250 mm Hg for 5 min. After cuff deflation, the brachial artery diameter was continuously monitored for 2-4 min to detect the peak artery diameter. FMD was determined as the percentage change in diameter from baseline to peak arterial diameter.
Endothelial dysfunction measured by FMD (Flow-Mediated Dilation) in patients with anti-osteoporotic treatment
时间窗: Visit 1: Day 0
FMD is a non-invasive technique. It was assessed using an ultrasound approach with a high-resolution linear array transducer coupled with computer-assisted analysis software. With this software, changes in the brachial artery could be assessed in real-time through an automated edge detection system. Longitudinal images of the brachial artery were obtained with the transducer fixed on the medial aspect of the dominant arm, approximately 2 cm above the medial epicondyle of the humerus. The transducer was fixed on the arm by a special arm-holding device. The brachial artery diameter was acquired as per a 30 s baseline measure, after which a cuff was placed around forearm (3 cm above wrist) and inflated to 250 mm Hg for 5 min. After cuff deflation, the brachial artery diameter was continuously monitored for 2-4 min to detect the peak artery diameter. FMD was determined as the percentage change in diameter from baseline to peak arterial diameter.
Endothelial dysfunction measured by FMD (Flow-Mediated Dilation) in patients with anti-osteoporotic treatment
时间窗: Visit 2: Day 0+1 year
FMD is a non-invasive technique. It was assessed using an ultrasound approach with a high-resolution linear array transducer coupled with computer-assisted analysis software. With this software, changes in the brachial artery could be assessed in real-time through an automated edge detection system. Longitudinal images of the brachial artery were obtained with the transducer fixed on the medial aspect of the dominant arm, approximately 2 cm above the medial epicondyle of the humerus. The transducer was fixed on the arm by a special arm-holding device. The brachial artery diameter was acquired as per a 30 s baseline measure, after which a cuff was placed around forearm (3 cm above wrist) and inflated to 250 mm Hg for 5 min. After cuff deflation, the brachial artery diameter was continuously monitored for 2-4 min to detect the peak artery diameter. FMD was determined as the percentage change in diameter from baseline to peak arterial diameter.
Endothelial dysfunction measured by FMD (Flow-Mediated Dilation) in patients with anti-osteoporotic treatment
时间窗: Visit 3: Day 0+2 years
FMD is a non-invasive technique. It was assessed using an ultrasound approach with a high-resolution linear array transducer coupled with computer-assisted analysis software. With this software, changes in the brachial artery could be assessed in real-time through an automated edge detection system. Longitudinal images of the brachial artery were obtained with the transducer fixed on the medial aspect of the dominant arm, approximately 2 cm above the medial epicondyle of the humerus. The transducer was fixed on the arm by a special arm-holding device. The brachial artery diameter was acquired as per a 30 s baseline measure, after which a cuff was placed around forearm (3 cm above wrist) and inflated to 250 mm Hg for 5 min. After cuff deflation, the brachial artery diameter was continuously monitored for 2-4 min to detect the peak artery diameter. FMD was determined as the percentage change in diameter from baseline to peak arterial diameter.
Endothelial dysfunction measured by FMD (Flow-Mediated Dilation) in patients with anti-osteoporotic treatment
时间窗: Visit 4: Day 0+3 years
FMD is a non-invasive technique. It was assessed using an ultrasound approach with a high-resolution linear array transducer coupled with computer-assisted analysis software. With this software, changes in the brachial artery could be assessed in real-time through an automated edge detection system. Longitudinal images of the brachial artery were obtained with the transducer fixed on the medial aspect of the dominant arm, approximately 2 cm above the medial epicondyle of the humerus. The transducer was fixed on the arm by a special arm-holding device. The brachial artery diameter was acquired as per a 30 s baseline measure, after which a cuff was placed around forearm (3 cm above wrist) and inflated to 250 mm Hg for 5 min. After cuff deflation, the brachial artery diameter was continuously monitored for 2-4 min to detect the peak artery diameter. FMD was determined as the percentage change in diameter from baseline to peak arterial diameter.
次要结局
- Microcirculation measurement by FLD (Flow Laser Doppler), PeriFlux® (Perimed)(Visit 5: Day 0+4 years)
- Evaluation of the Abdominal Aorta Calcification (AAC) (Kauppila score)(Visit 5: Day 0+4 years)
- The numerical pain scale(Visit 5: Day 0+4 years)
- Dickkopf-related protein 1 (DKK1) dosage(Visit 5: Day 0+4 years)
- Measurement of digital volume increase by RHI (Reactive hyperhemia index), (Endo-PAT2000; Itamar Medical Ltd, Israel).(Visit 5: Day 0+4 years)
- Sphygmocor CPV® (Atcor Medical) large artery stiffness measurement (PWV)(Visit 5: Day 0+4 years)
- The 36-Item Short Form Survey (SF-36)(Visit 5: Day 0+4 years)
- Osteocalcin dosage(Visit 5: Day 0+4 years)
- Irisin dosage(Visit 5: Day 0+4 years)
- Strength, Assistance with walking, Rising from a chair, Climbing stairs, and Falls (SARC-F) questionnaire(Visit 5: Day 0+4 years)
- Short Physical Performance Battery (SPPB) Questionnaire(Visit 1: Day 0)
- SPPB Questionnaire(Visit 5: Day 0+4 years)
- Evaluation of the muscular strength(Visit 5: Day 0+4 years)
- Body composition measurement on Dual energy X-ray Absorptiometry (DXA)(Visit 5: Day 0+4 years)
- The Pittsburgh Sleep Quality Index (PSQI)(Visit 5: Day 0+4 years)
- N-terminal propeptide of procollagen type 1 (P1NP) dosage(Visit 5: Day 0+4 years)
- Sclerostin dosage(Visit 5: Day 0+4 years)
- Periostin dosage(Visit 5: Day 0+4 years)
- C-terminal telopeptides of collagen type 1 (CTX) dosage(Visit 5: Day 0+4 years)
- Identification of predictive factors of treatment effectiveness according to variations in vascular and endothelial function parameters and pain, which will be studied first as quantitative parameters and then as categorical data.(Through study completion, an average of 1 year)
- The Brief Pain Inventory Questionnaire (BPI)(Visit 5: Day 0+4 years)
- The Hospital Anxiety and Depression Scale (HAD)(Visit 5: Day 0+4 years)
- Distribution of gene polymorphisms using OpenArray technology(Visit 1: Day 0)
- MicroRNA analysis using OpenArray technology(Visit 5: Day 0+4 years)
- Study of the microbiota(Visit 5: Day 0+4 years)
- The 36-Item Short Form Survey (SF-36)(Visit 4: Day 0+3 years)
- The 36-Item Short Form Survey (SF-36)(Visit 3: Day 0+2 years)
- Measurement of digital volume increase by RHI (Reactive hyperhemia index), (Endo-PAT2000; Itamar Medical Ltd, Israel).(Visit 1: Day 0)
- Measurement of digital volume increase by RHI (Reactive hyperhemia index), (Endo-PAT2000; Itamar Medical Ltd, Israel).(Visit 2: Day 0+1 year)
- Measurement of digital volume increase by RHI (Reactive hyperhemia index), (Endo-PAT2000; Itamar Medical Ltd, Israel).(Visit 3: Day 0+2 years)
- Measurement of digital volume increase by RHI (Reactive hyperhemia index), (Endo-PAT2000; Itamar Medical Ltd, Israel).(Visit 4: Day 0+3 years)
- Microcirculation measurement by FLD (Flow Laser Doppler), PeriFlux® (Perimed)(Visit 1: Day 0)
- Microcirculation measurement by FLD (Flow Laser Doppler), PeriFlux® (Perimed)(Visit 2: Day 0+1 year)
- Microcirculation measurement by FLD (Flow Laser Doppler), PeriFlux® (Perimed)(Visit 3: Day 0+2 years)
- Microcirculation measurement by FLD (Flow Laser Doppler), PeriFlux® (Perimed)(Visit 4: Day 0+3 years)
- Sphygmocor CPV® (Atcor Medical) large artery stiffness measurement (PWV)(Visit 1: Day 0)
- Sphygmocor CPV® (Atcor Medical) large artery stiffness measurement (PWV)(Visit 2: Day 0+1 year)
- Sphygmocor CPV® (Atcor Medical) large artery stiffness measurement (PWV)(Visit 3: Day 0+2 years)
- Sphygmocor CPV® (Atcor Medical) large artery stiffness measurement (PWV)(Visit 4: Day 0+3 years)
- Evaluation of the Abdominal Aorta Calcification (AAC) (Kauppila score)(Preselection visit V0: Day 0-1 month (D0-1))
- Strength, Assistance with walking, Rising from a chair, Climbing stairs, and Falls (SARC-F) questionnaire(Visit 1: Day 0)
- Strength, Assistance with walking, Rising from a chair, Climbing stairs, and Falls (SARC-F) questionnaire(Visit 2: Day 0+1 year)
- Strength, Assistance with walking, Rising from a chair, Climbing stairs, and Falls (SARC-F) questionnaire(Visit 3: Day 0+2 years)
- The numerical pain scale(Visit 4: Day 0+3 years)
- Strength, Assistance with walking, Rising from a chair, Climbing stairs, and Falls (SARC-F) questionnaire(Visit 4: Day 0+3 years)
- SPPB Questionnaire(Visit 2: Day 0+1 year)
- SPPB Questionnaire(Visit 3: Day 0+2 years)
- SPPB Questionnaire(Visit 4: Day 0+3 years)
- The 36-Item Short Form Survey (SF-36)(Visit 1: Day 0)
- Evaluation of the muscular strength(Visit 1: Day 0)
- Evaluation of the muscular strength(Visit 2: Day 0+1 year)
- Evaluation of the muscular strength(Visit 3: Day 0+2 years)
- Evaluation of the muscular strength(Visit 4: Day 0+3 years)
- Body composition measurement on Dual energy X-ray Absorptiometry (DXA)(Preselection visit V0: Day 0-1 month (D0-1))
- Body composition measurement on Dual energy X-ray Absorptiometry (DXA)(Visit 3: Day 0+2 years)
- The Pittsburgh Sleep Quality Index (PSQI)(Visit 1: Day 0)
- The Pittsburgh Sleep Quality Index (PSQI)(Visit 2: Day 0+1 year)
- The Pittsburgh Sleep Quality Index (PSQI)(Visit 3: Day 0+2 years)
- The Pittsburgh Sleep Quality Index (PSQI)(Visit 4: Day 0+3 years)
- The Brief Pain Inventory Questionnaire (BPI)(Visit 1: Day 0)
- The Brief Pain Inventory Questionnaire (BPI)(Visit 2: Day 0+1 year)
- The Brief Pain Inventory Questionnaire (BPI)(Visit 3: Day 0+2 years)
- The Brief Pain Inventory Questionnaire (BPI)(Visit 4: Day 0+3 years)
- The numerical pain scale(Visit 1: Day 0)
- The numerical pain scale(Visit 2: Day 0+1 year)
- The numerical pain scale(Visit 3: Day 0+2 years)
- The Hospital Anxiety and Depression Scale (HAD)(Visit 1: Day 0)
- The Hospital Anxiety and Depression Scale (HAD)(Visit 2: Day 0+1 year)
- The Hospital Anxiety and Depression Scale (HAD)(Visit 3: Day 0+2 years)
- The Hospital Anxiety and Depression Scale (HAD)(Visit 4: Day 0+3 years)
- The 36-Item Short Form Survey (SF-36)(Visit 2: Day 0+1 year)
- Sclerostin dosage(Visit 1: Day 0)
- Sclerostin dosage(Visit 2: Day 0+1 year)
- Sclerostin dosage(Visit 3: Day 0+2 years)
- Sclerostin dosage(Visit 4: Day 0+3 years)
- Osteocalcin dosage(Visit 1: Day 0)
- Osteocalcin dosage(Visit 2: Day 0+1 year)
- Osteocalcin dosage(Visit 3: Day 0+2 years)
- Osteocalcin dosage(Visit 4: Day 0+3 years)
- Periostin dosage(Visit 1: Day 0)
- Periostin dosage(Visit 2: Day 0+1 year)
- Periostin dosage(Visit 3: Day 0+2 years)
- Periostin dosage(Visit 4: Day 0+3 years)
- Irisin dosage(Visit 1: Day 0)
- Irisin dosage(Visit 2: Day 0+1 year)
- Irisin dosage(Visit 3: Day 0+2 years)
- Irisin dosage(Visit 4: Day 0+3 years)
- N-terminal propeptide of procollagen type 1 (P1NP) dosage(Visit 1: Day 0)
- N-terminal propeptide of procollagen type 1 (P1NP) dosage(Visit 2: Day 0+1 year)
- N-terminal propeptide of procollagen type 1 (P1NP) dosage(Visit 3: Day 0+2 years)
- N-terminal propeptide of procollagen type 1 (P1NP) dosage(Visit 4: Day 0+3 years)
- Dickkopf-related protein 1 (DKK1) dosage(Visit 1: Day 0)
- Dickkopf-related protein 1 (DKK1) dosage(Visit 2: Day 0+1 year)
- Dickkopf-related protein 1 (DKK1) dosage(Visit 3: Day 0+2 years)
- Dickkopf-related protein 1 (DKK1) dosage(Visit 4: Day 0+3 years)
- C-terminal telopeptides of collagen type 1 (CTX) dosage(Visit 1: Day 0)
- C-terminal telopeptides of collagen type 1 (CTX) dosage(Visit 2: Day 0+1 year)
- C-terminal telopeptides of collagen type 1 (CTX) dosage(Visit 3: Day 0+2 years)
- C-terminal telopeptides of collagen type 1 (CTX) dosage(Visit 4: Day 0+3 years)
- MicroRNA analysis using OpenArray technology(Visit 1: Day 0)
- MicroRNA analysis using OpenArray technology(Visit 2: Day 0+1 year)
- MicroRNA analysis using OpenArray technology(Visit 3: Day 0+2 years)
- MicroRNA analysis using OpenArray technology(Visit 4: Day 0+3 years)
- Study of the microbiota(Visit 1: Day 0)
- Study of the microbiota(Visit 2: Day 0+1 year)
- Study of the microbiota(Visit 3: Day 0+2 years)
- Study of the microbiota(Visit 4: Day 0+3 years)