RecruitingNot ApplicableNCT05228262

Vascular Function, Sarcopenia and Pain in Postmenopausal Osteoporosis

Study on Vascular Function, Sarcopenia and Pain in Treated Postmenopausal Osteoporosis

Sponsor

University Hospital, Clermont-Ferrand

Enrollment

150 participants

Start Date

Feb 15, 2022

Study Type

INTERVENTIONAL

Conditions

Osteoporosis, Postmenopausal

Summary

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

Sex: FEMALEMin Age: 50 Years

Inclusion Criteria3

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.

Exclusion Criteria4

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.

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Interventions

OTHERCohort follow-up

* 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.