MicroRNA and bone markers linked to response to romosozumab and abaloparatide in postmenopausal osteoporosis
Official title: MicroRNA and Circulating Markers Predictive of the Therapeutic Response to Romosozumab and Abaloparatide Treatment in Women With Postmenopausal Osteoporosis
Run by Istituto Auxologico Italiano · NCT07616401 · Data updated 2026-11-12
Researchers will test whether microRNA and other bone markers can predict how well postmenopausal women with osteoporosis respond to romosozumab and abaloparatide.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 50 Years and up |
| Sex | Women only |
| Enrollment | 42 (estimated) |
| Sponsor | Istituto Auxologico Italiano Academic / other |
| Drugs / interventions | denosumab, romosozumab |
| Locations | 2 sites (Miano, Lombardy and 1 other locations) |
| Status | Recruiting |
| Started | August 31, 2025 |
| Main results expected | August 31, 2029 |
| Study ends | August 31, 2029 |
| Registry record updated | June 1, 2026 |
| Trial ID | NCT07616401 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Postmenopausal women with densitometrically confirmed osteoporosis who are suitable for anabolic or antiresorptive therapy and have normal calcium intake.
✕Probably not a fit
Women who do not show biomarker patterns associated with favorable response may not experience improved outcomes with the tested therapies.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study is an interventional, biomarker-driven investigation in postmenopausal women with osteoporosis. It will analyze microRNA profiles and bone metabolism markers to see if they correlate with treatment response to romosozumab and abaloparatide. Participants will be women with osteoporosis who are already candidates for anabolic or antiresorptive therapies, and the study will compare biomarker patterns with outcomes related to bone formation and resorption. The approach aims to identify signals that might guide personalized therapy by matching patients to the most effective treatment based on their molecular markers. The trial is conducted at two Lombardy centers in Italy under the lead sponsorship of Istituto Auxologico Italiano.
Why it matters
Potential benefit: If successful, the study could help tailor osteoporosis treatment to individuals by using biomarkers to predict who will benefit most from romosozumab or abaloparatide.
How similar studies have gone: Biomarker-guided approaches have shown promise in other bone and metabolic studies, but this exact microRNA/marker approach with romosozumab and abaloparatide is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Female sex * Postmenopause * Densitometric diagnosis of osteoporosis * Normal calcium diet * Supplement with cholecalciferol or calcifediol Exclusion Criteria: * Premenopause * Chronic therapy with glucocorticosteroids, or other treatments that may affect bone metabolism * Diseases and conditions that may affect bone metabolism
Where it's running
-
Istituto Auxologico Italiano IRCCS
Miano, Lombardy, Italy Recruiting -
IRCCS Ospedale Galeazzi Sant'Ambrogio
Milan, Lombardy, Italy Not yet recruiting
Study contacts
- Study coordinator: Sabrina Corbetta, Prof.
- Email: s.corbetta@auxologico.it
- Phone: +3902619111
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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.