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

NCT04153227 | Completed DMC

• 1 other identifier: CEIm 2019/643
• Study Type: observational
• Target: 112
• Locations: 1 country
• Sites: 1

Brief 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

Osteoporosis; Bladder Disease

Keywords

Osteoporosis; Trabecular bone score; FRAX; Radical cystectomy; Fracture risk; Metabolic acidosis; Vertebral fracture assessment; Bone mineral density; Urinary diversion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Trabecular bone score (TBS)

  Baseline

• Vertebral fractures

  Baseline

• Fracture Risk Assessment Tool (FRAX)

  Baseline

Other Outcomes (4)

• Number of patients with metabolic acidosis.

  Baseline

• Number of patients with Secondary hyperparathyroidism.

  Baseline

• Number of patients with Serum total 25(OH) vitamin D deficiency.

  Baseline

Interventions

Bone mineral density (BMD) DIAGNOSTIC_TEST

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

Trabecular bone score (TBS) DIAGNOSTIC_TEST

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).

Fracture risk Assessment Tool (FRAX) DIAGNOSTIC_TEST

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.

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Corporacion Parc Tauli: lead

Study Sites (1)

Hospital Universitari Parc Taulí

Sabadell, 08208, Spain

Location

MeSH Terms

Conditions

Osteoporosis; Urinary Bladder Diseases; Acidosis

Interventions

Bone Density

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Acid-Base Imbalance

Intervention Hierarchy (Ancestors)

Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Arturo Domínguez, MD

  Hospital Universitari Parc Taulí

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: November 4, 2019
• First Posted: November 6, 2019
• Study Start: January 1, 2018
• Primary Completion: April 25, 2024
• Study Completion: April 25, 2024
• Last Updated: August 29, 2024

Record last verified: 2024-08

Locations

ES (1)