Clinical trial Recruiting at 1 site Interventional Ages 50 and up Women only

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.

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Quick facts

Study typeInterventional
Ages50 Years and up
SexWomen only
Enrollment42 (estimated)
SponsorIstituto Auxologico Italiano
Academic / other
Drugs / interventionsdenosumab, romosozumab
Locations2 sites (Miano, Lombardy and 1 other locations)
StatusRecruiting
StartedAugust 31, 2025
Main results expectedAugust 31, 2029
Study endsAugust 31, 2029
Registry record updatedJune 1, 2026
Trial IDNCT07616401 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

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.