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

Completed

• Conditions: Osteoporosis; Bladder Disease

• Registration Number: NCT04153227
• Lead Sponsor: Corporacion Parc Tauli

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-01
• Study First Submitted: 2019-11-04
• Study First Submitted QC: 2019-11-05
• Study First Posted: 2019-11-06
• Primary Completion: 2024-04-25
• Study Completion: 2024-04-25
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-27
• Last Update Posted: 2024-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 112

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Bone mineral Density (BMD)	Baseline	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).

Secondary Outcome Measures

Name	Time	Method
Trabecular bone score (TBS)	Baseline	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).
Fracture Risk Assessment Tool (FRAX)	Baseline	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).
Vertebral fractures	Baseline	Presence of vertebral fractures evaluated by Vertebral Fracture Assessment (VFA)

Trial Locations

Locations (1)

Hospital Universitari Parc Taulí; 🇪🇸 Sabadell, Spain