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Osteoporosis, Trabecular Bone Score and Fracture Risk Assessment in Male Patients After Radical Cystectomy

NCT04153227 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 112

Last updated 2024-08-29

No results posted yet for this study

Summary

Radical cystectomy (RC) with ileal urinary diversion (UD) is a standard treatment for muscle-invasive bladder cancer. However, emerging evidence indicates that this procedure may significantly impact bone health. Patients with UDs have a 21-48% higher risk of experiencing a fragility fracture compared to the general population. The underlying mechanisms are not entirely understood, but one prevailing hypothesis implicates substantial bone mineral density (BMD) loss due to the metabolic changes induced by UD, particularly driven by metabolic acidosis.

Dual-energy X-ray absorptiometry (DXA) remains the gold standard for measuring BMD and provides an indirect assessment of fracture risk. However, the trabecular bone score (TBS), a non-invasive imaging technique that evaluates bone microarchitecture, offers additional insights into bone quality that are independent of BMD and enhances the understanding of bone strength and fracture resistance. Furthermore, the use of tools such as the FRAX® (Fracture Risk Assessment Tool) helps in identifying patients at higher risk of osteoporotic fractures by estimating the 10-year probability of major fractures (MOF) (spine, forearm, hip, or shoulder) and hip fractures (HIP) based on various clinical risk factors. The predictive accuracy of FRAX® can be further refined by incorporating femoral neck BMD and adjusting for TBS.

Osteoporosis in men is a frequently underdiagnosed and undertreated condition. This underdiagnosis is also evident in patients with UDs. This study aims to evaluate the prevalence of bone alterations in men post-RC, employing both BMD and TBS measurements. Additionally, it seeks to identify key risk factors and critically assess the utility of FRAX® as a screening tool for pinpointing patients at elevated fracture risk.

To the best of the investigator's knowledge it will be the first study assessing the bone health after RC evaluating BMD, TBS and the fracture risk using the FRAX algorithm.

Conditions

Interventions

DIAGNOSTIC_TEST

Bone mineral density (BMD)

Bone mineral density (BMD) is measured by Dual-energy X-ray absorptiometry (DXA). BMD provides a measure of bone mass.

DIAGNOSTIC_TEST

Trabecular bone score (TBS)

The Trabecular Bone Score (TBS) is a novel gray-level texture measurement that can be extracted from DXA images. TBS provides a measure of bone quality (bone microarchitecture).

DIAGNOSTIC_TEST

Fracture risk Assessment Tool (FRAX)

The Fracture risk Assessment Tool (FRAX) is a fracture risk calculator that estimates an individual's 10-year probability of incurring a hip or other major osteoporotic fracture.

Sponsors & Collaborators

  • Corporacion Parc Tauli

    lead OTHER

Principal Investigators

  • Arturo Domínguez, MD · Hospital Universitari Parc Taulí

Eligibility

Min Age
50 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-01
Primary Completion
2024-04-25
Completion
2024-04-25

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04153227 on ClinicalTrials.gov