Clinical trial Recruiting at 1 site Observational Ages 18 and up

Analyzing bone damage in patients with osteoporosis and fragility fractures

Official title: Image-guided Computational and Experimental Analyses of Fractured Patient's Bone (GAP)

Run by Politecnico di Milano · NCT04787679 · Data updated 2026-11-12

This study is testing how tiny changes in bones affect fracture risk in people with osteoporosis and fragility fractures who are having hip replacement surgery.

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment52 (estimated)
SponsorPolitecnico di Milano
Academic / other
Locations1 site (Miano, Milano)
StatusRecruiting
StartedNovember 9, 2020
Main results expectedJuly 9, 2026
Study endsAugust 9, 2028
Registry record updatedJanuary 29, 2026
Trial IDNCT04787679 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are adults aged 18 and older who are scheduled for primary hip replacement surgery and have undergone a routine preoperative CT scan.

Probably not a fit

Patients with non-osteoporotic bone diseases or those who have had previous hip replacements may 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 observational study aims to investigate the mechanisms of bone damage at the microscale in patients suffering from osteoporosis and fragility fractures. By utilizing advanced imaging techniques and computational models, the study seeks to understand how microstructural features of bone contribute to fracture risk. The research will involve patients undergoing primary hip replacement surgery, with a focus on validating computational models through experimental tests on human bones. The ultimate goal is to develop new fracture indices that can aid in early diagnosis and treatment strategies.

Why it matters

Potential benefit: If successful, this study could lead to improved diagnostic tools and treatment strategies for patients with osteoporosis, potentially reducing fracture risk.

How similar studies have gone: While there have been studies exploring bone damage mechanisms, this approach combining microscale imaging with computational modeling is relatively novel and has not been extensively tested in human bones.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Age: \>=18 years
* primary hip replacement
* Signature of informed consent
* Patients who have a routine preoperative CT scan

Exclusion criteria:

* Patients unrelated to the inclusion criteria of this study
* Bone disease (non-osteoporotic) such as to invalidate sample analysis, including but not limited to genetic disorders and bone tumors
* Patients with contralateral hip replacement and/or other synthetic means in the contralateral hip
* Patients with synthesis devices in the hip of interest

Where it's running

  • IRCCS Istituto Ortopedico Galeazzi
    Miano, Milano, Italy
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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.