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NCT Number: NCT04153227

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

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Key information

Conditions

Osteoporosis Acid-Base Imbalance Acidosis Bladder Disease Bone Diseases Bone Diseases, Metabolic Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Urinary Bladder Diseases Urogenital Diseases Urologic Diseases

Age range

50 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Hospital Universitari Parc Taulí

Sabadell, 08208, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Bone mineral Density (BMD)

    Time frame: 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 outcomes

  1. Trabecular bone score (TBS)

    Time frame: 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).

  2. Vertebral fractures

    Time frame: Baseline

    Presence of vertebral fractures evaluated by Vertebral Fracture Assessment (VFA)

  3. Fracture Risk Assessment Tool (FRAX)

    Time frame: 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).

Other outcomes

  1. Number of patients with metabolic acidosis.

    Time frame: Baseline

    Metabolic acidosis is considered if venous serum bicarbonate <22mmol/L

  2. Number of patients with Secondary hyperparathyroidism.

    Time frame: Baseline

    Secondary hiperparathyroidism is considered if Serum parathyroid hormone (PTH) >65 pg/mL

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

    Time frame: Baseline

    Serum total 25(OH) vitamine D deficiency is considered if <30 ng/mL

  4. Number of patients with moderate-severe chronic kidney disease

    Time frame: Baseline

    Glomerular filtration rate (GFR) <60 mL/min

Sponsors and collaborators

Lead sponsor

Corporacion Parc Tauli

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Nov 6, 2019
Registry last updated
Aug 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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