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Clinical Trial 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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT04153227
Study type Observational [Patient Registry]
Source Corporacion Parc Tauli
Contact Arturo Domínguez, MD
Phone +0034 937458407
Email adominguez@tauli.cat
Status Recruiting
Phase
Start date May 1, 2018
Completion date July 2020

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