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 type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 52 (estimated) |
| Sponsor | Politecnico di Milano Academic / other |
| Locations | 1 site (Miano, Milano) |
| Status | Recruiting |
| Started | November 9, 2020 |
| Main results expected | July 9, 2026 |
| Study ends | August 9, 2028 |
| Registry record updated | January 29, 2026 |
| Trial ID | NCT04787679 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
- Principal investigator: Luigi Zagra — IRCCS Istituto Ortopedico Galeazzi
- Study coordinator: Laura M Vergani
- Email: luigi.zagra@fastwebnet.it
- Phone: +393393758630
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Improving outcomes for patients with fragility fractures
This study is testing if a new support program for older adults with recent bone fractures can help them recover better than standard care that just provides education.
-
Surgeon-driven bone health referral for patients having lower limb joint replacement
This study is testing if sending patients with osteoporosis to a bone health specialist before getting lower limb joint replacement surgery can help reduce fractures and complications compared to regular care.
-
Preventing secondary hip fractures in postmenopausal women
This study is testing if a new treatment can help prevent additional hip fractures in postmenopausal women who have already broken a hip and are having surgery to fix it.
-
Role of LH and hCG in adults being evaluated for endocrine disorders
This study looks at whether levels of luteinizing hormone (LH) and hCG in adults undergoing endocrine evaluation relate to their disease presence and outcomes.
-
Can a blood marker called lumican reveal hidden fragility in postmenopausal osteoporosis
This study tests whether serum lumican levels can help identify hidden fragility risk in postmenopausal women beyond what bone density shows.
-
Functional Muscle-Bone Incongruity Index: A look at muscle strength and bone health in adults
This observational study tests a composite FKUI score using handgrip strength and hip/spine bone density to see if it better reflects musculoskeletal health than each measure alone in adults undergoing routine DXA.
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.