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

Osteoporosis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04153227
• Other study ID #: CEIm 2019/643
• Status: Recruiting
• Start date: May 1, 2018
• Est. completion date: July 2020

Study information

• Verified date: November 2019
• Source: Corporacion Parc Tauli
• Contact: Arturo Domínguez, MD
• Phone: +0034 937458407
• Email: adominguez[@]tauli.cat
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: July 2020
• Est. primary completion date: July 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bladder Disease
• Osteoporosis
• Urinary Bladder Diseases

Intervention

Diagnostic Test:
• Bone mineral density (BMD)
Bone mineral density (BMD) measured by Dual-energy X-ray absorptiometry (DXA).

Locations

Country	Name	City	State
Spain	Hospital Universitari Parc Taulí	Sabadell

Sponsors (1)

Lead Sponsor	Collaborator
Corporacion Parc Tauli

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of patients with metabolic acidosis.	Metabolic acidosis is considered if venous serum bicarbonate <23mmol/L	Baseline
Other	Number of patients with Secondary hyperparathyroidism.	Secondary hiperparathyroidism is considered if Serum parathyroid hormone (PTH) >65 pg/mL	Baseline
Other	Number of patients with Serum total 25(OH) vitamin D deficiency.	Serum total 25(OH) vitamine D deficiency is considered if <30 ng/mL	Baseline
Other	Number of patients with moderate-severe chronic kidney disease	Glomerular filtration rate (GFR) <60 mL/min	Baseline
Other	Number of patients with Hypoalbuminemia	Hypoalbuminemia is considered if Albumin < 34 g/L	Baseline
Primary	Number of patients with osteoporosis	Bone mineral density (BMD) measured by Dual-energy X-ray absorptiometry (DXA)	Baseline
Secondary	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
Secondary	Vertebral fractures	Presence of vertebral fractures evaluated by Vertebral Fracture Assessment (VFA)	Baseline
Secondary	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