Impact of Osteoporosis Treatment on Vascular Health and Pain in Postmenopausal Women
Official title: Study on Vascular Function, Sarcopenia and Pain in Treated Postmenopausal Osteoporosis
Run by University Hospital, Clermont-Ferrand · NCT05228262 · Data updated 2026-11-12
This study is testing how osteoporosis treatments affect heart health, pain, and quality of life in postmenopausal women.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 50 Years and up |
| Sex | Women only |
| Enrollment | 150 (estimated) |
| Sponsor | University Hospital, Clermont-Ferrand Academic / other |
| Drugs / interventions | denosumab, romosozumab |
| Locations | 1 site (Clermont-Ferrand) |
| Status | Recruiting |
| Started | February 15, 2022 |
| Main results expected | February 1, 2027 |
| Study ends | February 1, 2027 |
| Registry record updated | October 10, 2022 |
| Trial ID | NCT05228262 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are women aged 50 years or older with postmenopausal osteoporosis who are starting treatment with anti-osteoporotic drugs.
✕Probably not a fit
Patients with chronic renal failure or those with medical histories incompatible with the trial will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: While there have been studies on osteoporosis treatments, this specific approach integrating vascular function and sarcopenia is relatively novel.
Who can join: the full rules
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 it's running
-
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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.