Metabolic Assessment of Aging Men With Urinary Lithiasis
|ClinicalTrials.gov Identifier: NCT01246531|
Recruitment Status : Completed
First Posted : November 23, 2010
Last Update Posted : November 23, 2010
|Condition or disease|
|Urolithiasis and Aging Renal Calcul and Metabolic Diseases Urolithiasis and Osteoporosis|
Urolithiasis is a common disease, with an overall prevalence about 2% in the world. Accordingly growth of life expectancy, elderly people become more susceptible to present renal calculi.
The investigators have two purposes: (1) evaluate metabolic disturbances in aging men with urinary lithiasis, and (2) evaluate bone demineralization in aging men with renal calculi.
The investigators have made a case-control model. The case-group is compposed by men with more than fifty years-old who had their first lithiasic diagnosis (renal colic ou incidental finding) after that age. The control-group is compposed by men with more than fifty years-old who had never diagnosed with renal stones. So the investigators have excluded men with repetitive episodes of renal colic, that could be negatively influence the outcomes of aging factors on urinary lithiasis. All the people have to submitted to blood tests, 24-hour urinary samples, abdominal ultrassonography and abdominal X-ray (or abdominal CT, if necessary); and bone densitometry. The investigators hope to achieve reliable conclusions about urinary lithogenesis.
Blood tests: total calcium, ionized calcium, uric acid, phosphorus, creatinine, urea, testosterone and parathyroid hormone.
24-hour urinary sample(s): calcium, uric acid, creatinine, citrate, sodium, pH and volume. Patients of the case arm had to collect 6 24-hour urine samples, while the control arm had collected 3 24-hour urine samples.
Data were analyzed using the Fischer's exact, Chi-square and Mann-Whitney tests; a level of significance of 5% was adopted.
|Study Type :||Observational|
|Actual Enrollment :||42 participants|
|Observational Model:||Case Control|
|Official Title:||Clinical Investigation of Aging Men With Renal Stones: The Role of Bone Demineralization (Metabolic and Hormonal Assessment)|
|Study Start Date :||January 2008|
|Actual Primary Completion Date :||January 2010|
|Actual Study Completion Date :||January 2010|
Case arm: men above fifty years-old with urolithiasis
Control arm: men above fifty years-old without urolithiasis
- Hypocitraturia is the main metabolic disturbance in aging men with urinary lithiasis [ Time Frame: Two years ]Aging men that had initiated their clinical signs or symptoms of urinary lithiasis above fifty years-old, presented hypocitraturia like the most common metabolic disturbance in 24-hour urine analysis. This finding had been different when we look for younger renal stones formers. In these, hypercalciuria is the main metabolic disturbance. Idiopathic hypercalciuria could affect men in a precocious phase of their lives, because of the genetic basis. However hypocitraturia could be related with acidified status, secondarily to alimentary habits, mainly excessive protein and sodium diarily intake.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01246531
|University of São Paulo General Hospital|
|São Paulo, Brazil, 05403010|
|Principal Investigator:||Eduardo Mazzucchi, MD||University of São Paulo General Hospital - Division of Urology|