An observational study in Osteoporosis and Bladder Disease, sponsored by Corporacion Parc Tauli. Completed at 1 site in Spain. Open to male participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2024-08-29.
Sponsored by Corporacion Parc Tauli · Observational
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.
1,601 studies on the registry are indexed under Osteoporosis; 209 are open to participants now.
This study's enrollment of 112 is below the median of 160 across 455 observational studies indexed under Osteoporosis.
Browse Osteoporosis studies →Corporacion Parc Tauli is the lead sponsor of 167 studies on the registry; 25 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Males who underwent radical cystectomy with ileal urinary diversion (ileal conduit or neobladder).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bone mineral density (BMD) is measured by Dual-energy X-ray absorptiometry (DXA). BMD provides a measure of bone mass.
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).
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.
Bone mineral Density (BMD)
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).
Time frame: Baseline
Trabecular bone score (TBS)
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).
Time frame: Baseline
Vertebral fractures
Presence of vertebral fractures evaluated by Vertebral Fracture Assessment (VFA)
Time frame: Baseline
Fracture Risk Assessment Tool (FRAX)
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).
Time frame: Baseline
Number of patients with metabolic acidosis.
Metabolic acidosis is considered if venous serum bicarbonate \<22mmol/L
Time frame: Baseline
Number of patients with Secondary hyperparathyroidism.
Secondary hiperparathyroidism is considered if Serum parathyroid hormone (PTH) \>65 pg/mL
Time frame: Baseline
Number of patients with Serum total 25(OH) vitamin D deficiency.
Serum total 25(OH) vitamine D deficiency is considered if \<30 ng/mL
Time frame: Baseline
Number of patients with moderate-severe chronic kidney disease
Glomerular filtration rate (GFR) \<60 mL/min
Time frame: Baseline
Plan to share: Undecided
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Ran from Jan 2018 to primary completion in Apr 2024, 75 months.
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This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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