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

Study Overview
=================
Brief Summary
-----------------
Radical cystectomy is associated with a greater risk of fracture due to long-term metabolic consequences of intestinal urinary diversions. One of the mechanisms theoretically involved with bone loss after radical cystectomy is metabolic acidosis that inhibits osteoblast activity, stimulates osteoclast bone resorption and urinary calcium loss. Other factors as advanced age, diabetes or chronic renal failure may increase the effect of metabolic acidosis. Moreover, osteoporosis in men remains under-diagnosed and under-appreciated. Although metabolic and bone changes after radical cystectomy are well known, bone mineral density (BMD) or fracture risk assessment are not recommended in different international guidelines during follow-up. The objective of this study is to evaluate the fracture risk of male patients undergoing radical cystectomy after more than one year of follow-up. Fracture risk assessment will be performed by BMD to analyse the prevalence of osteoporosis, vertebral fractures and measurement of Trabecular Bone Score (TBS) in combination with the Fracture Risk Assessment Tool (FRAX). These results will be correlated with blood markers with the objective to determine independent risk factors for osteoporosis or bone fracture in this population. To the best of the investigator's knowledge this will be the first study assessing the fracture risk after radical cystectomy performance evaluating BMD and the probability of fracture at 10 years using the FRAX algorithm.

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

Conditions
-----------------
Osteoporosis, Bladder Disease

Intervention / Treatment
-----------------
* Diagnostic Test: Bone mineral density (BMD)


Participation Criteria
=================
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, hyperthyroidism or systemic lupus erythematosus. Patients treated with drugs known to interfere with bone metabolism (including hormonal treatment, biphosphonates or Denosumab) or previously diagnosed with osteoporosis. Patients with a history of hemodialysis or renal transplantation. Patients who are under active treatment with chemotherapy or immunotherapy due to bladder tumor progression or the appearance/progression of a second malignancy. Any patient who does not agree to participate or does not sign the informed consent

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Bone mineral density (BMD)|Bone mineral density (BMD) measured by Dual-energy X-ray absorptiometry (DXA).|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with osteoporosis | Bone mineral density (BMD) measured by Dual-energy X-ray absorptiometry (DXA) | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trabecular bone score | 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 | 
| Vertebral fractures | Presence of vertebral fractures evaluated by Vertebral Fracture Assessment (VFA) | Baseline | 
| FRAX Assessment Tool | 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) | Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Osteoporosis, Trabecular bone score, FRAX, Radical cystectomy, Fracture risk, Metabolic acidosis, Vertebral fracture assessment