Vascular Function, Sarcopenia and Pain in Postmenopausal Osteoporosis

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age50+
SponsorUniversity Hospital, Clermont-Ferrand

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Cohort follow-up

    Other intervention

    * Inclusion medical consultation, * Inclusion clinical examination, * Collection of biological samples (bone biomarkers, epigenetic biomarkers (microRNA)) and analysis of microbiota and genotyping, * Calculation of the Kauppila score on profile spine radiographs by the rheumatologist, * Cardiovascular investigations (FMD, "Flow-Mediated Dilation"); measurement of digital volume increase (RHI, "Reactive hyperhemia index"); measurement of microcirculatory perfusion of the skin at the hand (FLD, "Flow Laser Doppler") ; measurement of the stiffness of the main arteries (aorta) by the Pulse Wave Velocity (PWV), * Exploration of sarcopenia: questionnaires and tests: SARC-F, SPPB, muscle strength, * Quality of life component questionnaires Pittsburgh Sleep (PSQI), Numerical Scale (NS), Brief Pain Inventory (BPI), Hospital Anxiety and Depression scale (HADs), and 36-Item Short Form Survey (SF-36) Quality of Life Questionnaire.

Treatment groups

150 Participants
are divided into 1 treatment group
Group A: Cohort follow-upOther 1 intervention

Trial outcomes

Primary outcomes

1

Endothelial dysfunction measured by FMD (Flow-Mediated Dilation) in patients with anti-osteoporotic treatment

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.

Time frame
Visit 1: Day 0
2

Endothelial dysfunction measured by FMD (Flow-Mediated Dilation) in patients with anti-osteoporotic treatment

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.

Time frame
Visit 2: Day 0+1 year
3

Endothelial dysfunction measured by FMD (Flow-Mediated Dilation) in patients with anti-osteoporotic treatment

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.

Time frame
Visit 3: Day 0+2 years
4

Endothelial dysfunction measured by FMD (Flow-Mediated Dilation) in patients with anti-osteoporotic treatment

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.

Time frame
Visit 4: Day 0+3 years

Secondary outcomes

1

Measurement of digital volume increase by RHI (Reactive hyperhemia index), (Endo-PAT2000; Itamar Medical Ltd, Israel).

RHI is a non-invasive technique. It's measure with a digital plethysmographie device that records pulsatile fluctuations in digital volume at rest and during reactive hyperemia. For the RH-PAT procedure, a peripheral arterial tonometry probe was placed on the right index finger and a control tonometry probe was also placed on the left index finger to eliminate sympathetic nerve effects. In the RH-PAT procedure, the RHI value was calculated as the ratio of the reactive hyperemia between the two hands.

Time frame
Visit 1: Day 0
2

Measurement of digital volume increase by RHI (Reactive hyperhemia index), (Endo-PAT2000; Itamar Medical Ltd, Israel).

RHI is a non-invasive technique. It's measure with a digital plethysmographie device that records pulsatile fluctuations in digital volume at rest and during reactive hyperemia. For the RH-PAT procedure, a peripheral arterial tonometry probe was placed on the right index finger and a control tonometry probe was also placed on the left index finger to eliminate sympathetic nerve effects. In the RH-PAT procedure, the RHI value was calculated as the ratio of the reactive hyperemia between the two hands.

Time frame
Visit 2: Day 0+1 year
3

Measurement of digital volume increase by RHI (Reactive hyperhemia index), (Endo-PAT2000; Itamar Medical Ltd, Israel).

RHI is a non-invasive technique. It's measure with a digital plethysmographie device that records pulsatile fluctuations in digital volume at rest and during reactive hyperemia. For the RH-PAT procedure, a peripheral arterial tonometry probe was placed on the right index finger and a control tonometry probe was also placed on the left index finger to eliminate sympathetic nerve effects. In the RH-PAT procedure, the RHI value was calculated as the ratio of the reactive hyperemia between the two hands.

Time frame
Visit 3: Day 0+2 years
4

Measurement of digital volume increase by RHI (Reactive hyperhemia index), (Endo-PAT2000; Itamar Medical Ltd, Israel).

RHI is a non-invasive technique. It's measure with a digital plethysmographie device that records pulsatile fluctuations in digital volume at rest and during reactive hyperemia. For the RH-PAT procedure, a peripheral arterial tonometry probe was placed on the right index finger and a control tonometry probe was also placed on the left index finger to eliminate sympathetic nerve effects. In the RH-PAT procedure, the RHI value was calculated as the ratio of the reactive hyperemia between the two hands.

Time frame
Visit 4: Day 0+3 years

Other outcomes

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