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

Impact on Bone Health in Patients Undergoing Radical Cystectomy: Prevalence of Osteoporosis, Trabecular Bone Score (TBS) Assessment and Fracture Risk by FRAX in Male Patients After One Year of Radical Cystectomy

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.

Study Overview

• Status: Completed
• Conditions: Osteoporosis; Bladder Disease
• Intervention / Treatment: Diagnostic test: Bone mineral density (BMD); Diagnostic test: Trabecular bone score (TBS); Diagnostic test: Fracture risk Assessment Tool (FRAX)

• Study Type: Observational
• Enrollment (Actual): 112

Contacts and Locations

Study Locations

• Spain
  • Sabadell, Spain, 08208
    • Hospital Universitari Parc Tauli

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Males who underwent radical cystectomy with ileal urinary diversion (ileal conduit or neobladder).

Description

Inclusion Criteria:

• All patients who understand, agree to participate and sign the informed consent.
• Males older than 50 years old.
• Patients undergoing radical cystectomy with ileal conduit or neobladder.
• Time over one year after radical cystectomy.

Exclusion Criteria:

• Female gender.
• Males below 50 years old.
• Radical cystectomy performed less than one year before.
• Radical cystectomy with cutaneous ureterostomy.
• Patients diagnosed with primary hyperparathyroidism.
• Patients receiving treatments that could influence bone metabolism, such as antiresorptive agents (including bisphosphonates or denosumab), chronic corticosteroids, androgen deprivation therapy for prostate cancer. Patients receiving treatment with Vitamin D were not excluded.
• Patients previously diagnosed with osteoporosis.
• Patients with a history of hemodialysis or renal transplantation.
• Patients receiving systemic cancer therapies for bladder tumor progression or other malignancies.
• Any patient who does not agree to participate or does not sign the informed consent

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bone mineral Density (BMD)	BMD values were categorized according to World Health Organization (WHO) criteria at any of the three measured sites: normal (T-score ≥ -1 SD), osteopenia (T-score between -1 and -2.5 SD), and osteoporosis (T-score ≤ -2.5 SD).	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vertebral fractures	Presence of vertebral fractures evaluated by Vertebral Fracture Assessment (VFA)	Baseline
Trabecular bone score (TBS)	Trabecular bone score (TBS) is a lumbar spine dual-energy absorptiometry texture index, which provides information on microarchitecture skeletal quality partially independent of BMD (TBS values >1.310 normal; TBS: 1.310-1.230 microarchitecture partially degraded; TBS <1.230 microarchitecture degraded).	Baseline
Fracture Risk Assessment Tool (FRAX)	FRAX provides country-specific algorithms for estimating individualized 10-year probability of hip and major osteoporotic fracture (FRAX with and without BMD and FRAX with TBS). Criteria for starting antiresorptive treatment in Spain: Risk of major osteoporotic fracture at 10 years ≥7.5% (with BMD) or ≥10% (without BMD) or risk of hip fracture ≥3% (with or without BMD).	Baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with Secondary hyperparathyroidism.	Secondary hiperparathyroidism is considered if Serum parathyroid hormone (PTH) >65 pg/mL	Baseline
Number of patients with Serum total 25(OH) vitamin D deficiency.	Serum total 25(OH) vitamine D deficiency is considered if <30 ng/mL	Baseline
Number of patients with moderate-severe chronic kidney disease	Glomerular filtration rate (GFR) <60 mL/min	Baseline
Number of patients with metabolic acidosis.	Metabolic acidosis is considered if venous serum bicarbonate <22mmol/L	Baseline

Collaborators and Investigators

• Sponsor: Corporacion Parc Tauli
• Investigators: Principal Investigator: Arturo Domínguez, MD, Hospital Universitari Parc Tauli

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): April 25, 2024
• Study Completion (Actual): April 25, 2024

Study Registration Dates

• First Submitted: November 4, 2019
• First Submitted That Met QC Criteria: November 5, 2019
• First Posted (Actual): November 6, 2019

Study Record Updates

• Last Update Posted (Actual): August 29, 2024
• Last Update Submitted That Met QC Criteria: August 27, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Osteoporosis; Radical cystectomy; Bone mineral density; Trabecular bone score; FRAX; Fracture risk; Metabolic acidosis; Vertebral fracture assessment; Urinary diversion
• Additional Relevant MeSH Terms: Metabolic Diseases; Urologic Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Osteoporosis; Urinary Bladder Diseases
• Other Study ID Numbers: CEIm 2019/643

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No