Impact of Osteoporosis Treatment on Vascular Health and Pain in Postmenopausal Women
Study on Vascular Function, Sarcopenia and Pain in Treated Postmenopausal Osteoporosis
This study is testing how osteoporosis treatments affect heart health, pain, and quality of life in postmenopausal women.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 50 Years and up |
| Sex | Female |
| Sponsor | University Hospital, Clermont-Ferrand Academic / other |
| Drugs / interventions | denosumab, romosozumab |
| Locations | 1 site (Clermont-Ferrand) |
| Trial ID | NCT05228262 on ClinicalTrials.gov |
What this trial studies
This study follows a group of postmenopausal women diagnosed with osteoporosis who are receiving anti-osteoporotic treatments. It aims to evaluate how these treatments affect vascular function, cardiovascular health, sarcopenia, pain levels, and overall quality of life. The study involves multiple visits for functional assessments and the collection of biological samples to explore genetic and epigenetic factors related to osteoporosis. Additionally, it seeks to understand the role of microbiota in these patients and identify therapeutic response profiles.
Who should consider this trial
Good fit: Ideal candidates are women aged 50 years or older with postmenopausal osteoporosis who are starting treatment with anti-osteoporotic drugs.
Not a fit: Patients with chronic renal failure or those with medical histories incompatible with the trial will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for osteoporosis that enhance vascular health and reduce pain in postmenopausal women.
How similar studies have performed: While there have been studies on osteoporosis treatments, this specific approach integrating vascular function and sarcopenia is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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.
Where this trial is running
Clermont-Ferrand
- CHU de Clermont-Ferrand — Clermont-Ferrand, France (Recruiting)
Study contacts
- Principal investigator: Marie-Eva Pickering — University Hospital, Clermont-Ferrand
- Study coordinator: Lise LACLAUTRE
- Email: promo_interne_drci@chu-clermontferrand.fr
- Phone: +33473754963
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.