NCT04153227Completed
Osteoporosis, Trabecular Bone Score and Fracture Risk Assessment in Male Patients After Radical Cystectomy
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
Source: ClinicalTrials.gov · Last updated 29 Aug 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 112 (actual)
- First submitted
- 4 Nov 2019
- Start date
- 1 Jan 2018
- Primary completion date
- 25 Apr 2024
- Lead sponsor
- Corporacion Parc Tauli
- Diseases
- Osteoporosis
- NCT number
- NCT04153227
What you commit to
- Study type: Observational
- Participants enrolled: 112
- From 1 Jan 2018 to the primary completion date, 25 Apr 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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 receiving systemic cancer therapies for bladder tumor progression or other malignancies.
Other illness
- Patients with a history of hemodialysis or renal transplantation.
Age
- Males below 50 years old.
Other
- Female gender.
- Radical cystectomy performed less than one year before.
- Radical cystectomy with cutaneous ureterostomy.
- Patients diagnosed with primary hyperparathyroidism.
- Any patient who does not agree to participate or does not sign the informed consent
Who the study is looking for
- 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.
Age in the registry: 50 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Universitari Parc Taulí Coordinator of this site? Confirm its status | Sabadell | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.