OsteoporosisNCT04153227
Osteoporosis, Trabecular Bone Score and Fracture Risk Assessment in Male Patients After Radical Cystectomy
An observational study of Osteoporosis and Bladder Disease, run by Corporacion Parc Tauli at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Osteoporosis, Bladder Disease
- What is being tested?
- Bone mineral density (BMD), Trabecular bone score (TBS) and Fracture risk Assessment Tool (FRAX)
- How many people
- 112 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2018to 25 Apr 2024
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Males who underwent radical cystectomy with ileal urinary diversion (ileal conduit or neobladder).
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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.
- Conditions
- Osteoporosis, Bladder Disease
- Being tested
- Bone mineral density (BMD), Trabecular bone score (TBS), Fracture risk Assessment Tool (FRAX)
- Keywords
- Osteoporosis, Trabecular bone score, FRAX, Radical cystectomy, Fracture risk, Metabolic acidosis, Vertebral fracture assessment, Bone mineral density, Urinary diversion
- Medical subject headings
- Osteoporosis, Urinary Bladder Diseases, Acidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone mineral density (BMD)Diagnostic test
Bone mineral density (BMD) is measured by Dual-energy X-ray absorptiometry (DXA). BMD provides a measure of bone mass.
Trabecular bone score (TBS)Diagnostic test
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).
Fracture risk Assessment Tool (FRAX)Diagnostic test
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline
Secondary outcomes (3)
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).
Measured: Baseline
Vertebral fractures
Presence of vertebral fractures evaluated by Vertebral Fracture Assessment (VFA)
Measured: 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).
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2019
- Study start1 Jan 2018
- Primary completion25 Apr 2024
- Study completion25 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 112 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Corporacion Parc Tauli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arturo Dominguez Garcia, Parc Taulí Hospital Universitari
- Investigators
- Arturo Domínguez, MD, Principal investigator, Hospital Universitari Parc Taulí
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04153227
- Sponsor's protocol ID
- CEIm 2019/643
- Status last verified
- Aug 2024
- First submitted
- 4 Nov 2019
- Last updated
- 29 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04153227
- Acronym / sponsor ID
- CEIm 2019/643
- Conditions
- Osteoporosis, Bladder Disease
- Keywords
- Osteoporosis, Trabecular bone score, FRAX, Radical cystectomy, Fracture risk, Metabolic acidosis, Vertebral fracture assessment, Bone mineral density
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Corporacion Parc TauliUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 25 Apr 2024 (actual)
- Study completion
- 25 Apr 2024 (actual)
- First posted
- 6 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Males who underwent radical cystectomy with ileal urinary diversion (ileal conduit or neobladder).
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bone mineral density (BMD)Bone mineral density (BMD) is measured by Dual-energy X-ray absorptiometry (DXA). BMD provides a measure of bone mass. | Diagnostic test | – |
| Trabecular bone score (TBS)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). | Diagnostic test | – |
| Fracture risk Assessment Tool (FRAX)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. | Diagnostic test | – |
Primary outcome
Bone mineral Density (BMD)
Time frame: Baseline
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).
3 secondary outcomes
Trabecular bone score (TBS)
Time frame: Baseline
Vertebral fractures
Time frame: Baseline
Fracture Risk Assessment Tool (FRAX)
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arturo Domínguez, MD principal investigator
Hospital Universitari Parc Taulí
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoporosis and Bladder Disease, run by Corporacion Parc Tauli at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone mineral Density (BMD) (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2024.