Clinical trial NCT04153227: Osteoporosis, Trabecular Bone Score and Fracture Risk Assessment in Male Patients After Radical Cystectomy
Official 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoporosis
Bladder Disease
Keywords: Osteoporosis
Trabecular bone score
FRAX
Radical cystectomy
Fracture risk
Metabolic acidosis
Vertebral fracture assessment
Bone mineral density
Urinary diversion
Lead sponsor: Corporacion Parc Tauli
Sponsor class: OTHER
First posted: 2019-11-06
Enrollment: 112
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Males who underwent radical cystectomy with ileal urinary diversion (ileal conduit or neobladder).

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.


Eligibility criteria: 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

Primary outcomes:
measure: Bone mineral Density (BMD)
timeFrame: Baseline
Secondary outcomes:
measure: Trabecular bone score (TBS)
timeFrame: Baseline
measure: Vertebral fractures
timeFrame: Baseline
measure: Fracture Risk Assessment Tool (FRAX)
timeFrame: Baseline
Other outcomes:
measure: Number of patients with metabolic acidosis.
timeFrame: Baseline
measure: Number of patients with Secondary hyperparathyroidism.
timeFrame: Baseline
measure: Number of patients with Serum total 25(OH) vitamin D deficiency.
timeFrame: Baseline
measure: Number of patients with moderate-severe chronic kidney disease
timeFrame: Baseline
Locations:
city: Sabadell
country: Spain
facility: Hospital Universitari Parc Taulí
Study officials:
affiliation: Hospital Universitari Parc Taulí
name: Arturo Domínguez, MD
role: PRINCIPAL_INVESTIGATOR
References: