Clinical trial NCT01246531: Metabolic Assessment of Aging Men With Urinary Lithiasis
Official title: Clinical Investigation of Aging Men With Renal Stones: The Role of Bone Demineralization (Metabolic and Hormonal Assessment)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urolithiasis and Aging
Renal Calcul and Metabolic Diseases
Urolithiasis and Osteoporosis
Keywords: Urolithiasis
Renal calculi
Aging
Osteoporosis
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2010-11-23
Enrollment: 42
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients from Urological Division of University of São Paulo General Hospital, in São Paulo (Brazil). Towards data bank, we called patients above fifty years-old who had urolithiasis diagnosis. Patients with benign prostate hyperplasia, above fifty years-old, had called to the control group.

Brief summary: Urinary lithiasis is a common disease on young adults, but not so far on aging people. Nowadays, the investigators are seeing a gradative growth on men above sixty years old, mainly in industrialized countries. The purpose of this study is to investigate metabolic aspects of aging men with renal stones, towards blood tests, 24 hour-urinary samples, imagenological exams and bone densitometry. The investigators have made a case-control model.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Men above fifty years-old with urolithiasis diagnosis (case arm)
* Men above fifty years-old without urolithiasis diagnosis (control arm)

Exclusion Criteria:

* Urolithiasis diagnosis (clinical or incidental) before fifty years-old.
* Urinary culture positive

Primary outcomes:
measure: Hypocitraturia is the main metabolic disturbance in aging men with urinary lithiasis
timeFrame: Two years
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: University of São Paulo General Hospital
Study officials:
affiliation: University of São Paulo General Hospital - Division of Urology
name: Eduardo Mazzucchi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Usui Y, Matsuzaki S, Matsushita K, Shima M. Urolithiasis in geriatric patients. Tokai J Exp Clin Med. 2003 Jul;28(2):81-7.
citation: 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.
citation: 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.
citation: 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.
citation: 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.