Metabolic Assessment of Aging Men With Urinary Lithiasis
NCT ID: NCT01246531
Last Updated: 2010-11-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
42 participants
OBSERVATIONAL
2008-01-31
2010-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Urolithiasis
Case arm: men above fifty years-old with urolithiasis
No interventions assigned to this group
Control
Control arm: men above fifty years-old without urolithiasis
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Men above fifty years-old without urolithiasis diagnosis (control arm)
Exclusion Criteria
* Urinary culture positive
50 Years
MALE
Yes
Sponsors
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University of Sao Paulo General Hospital
OTHER
Responsible Party
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University of São Paulo General Hospital
Principal Investigators
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Eduardo Mazzucchi, MD
Role: PRINCIPAL_INVESTIGATOR
University of São Paulo General Hospital - Division of Urology
Locations
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University of São Paulo General Hospital
São Paulo, São Paulo, Brazil
Countries
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References
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Usui Y, Matsuzaki S, Matsushita K, Shima M. Urolithiasis in geriatric patients. Tokai J Exp Clin Med. 2003 Jul;28(2):81-7.
Vella M, Karydi M, Coraci G, Oriti R, Melloni D. Pathophysiology and clinical aspects of urinary lithiasis. Urol Int. 2007;79 Suppl 1:26-31. doi: 10.1159/000104438.
Ebeling PR. Clinical practice. Osteoporosis in men. N Engl J Med. 2008 Apr 3;358(14):1474-82. doi: 10.1056/NEJMcp0707217. No abstract available.
Aw D, Silva AB, Palmer DB. Immunosenescence: emerging challenges for an ageing population. Immunology. 2007 Apr;120(4):435-46. doi: 10.1111/j.1365-2567.2007.02555.x. Epub 2007 Feb 15.
Freitas Junior CH, Mazzucchi E, Danilovic A, Brito AH, Srougi M. Metabolic assessment of elderly men with urolithiasis. Clinics (Sao Paulo). 2012;67(5):457-61. doi: 10.6061/clinics/2012(05)09.
Other Identifiers
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0688/07
Identifier Type: -
Identifier Source: org_study_id