Metabolic Assessment of Aging Men With Urinary Lithiasis

Renal Calcul and Metabolic Diseases Clinical Trial

Official title:

Clinical Investigation of Aging Men With Renal Stones: The Role of Bone Demineralization (Metabolic and Hormonal Assessment)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01246531
• Other study ID #: 0688/07
• Status: Completed
• Phase: N/A
• First received: November 22, 2010
• Last updated: November 22, 2010
• Start date: January 2008
• Est. completion date: January 2010

Study information

• Verified date: October 2010
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 50 Years and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Metabolic Diseases
• Osteoporosis
• Renal Calcul and Metabolic Diseases
• Urolithiasis
• Urolithiasis and Aging
• Urolithiasis and Osteoporosis

Locations

Country	Name	City	State
Brazil	University of São Paulo General Hospital	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

References & Publications (4)

Aw D, Silva AB, Palmer DB. Immunosenescence: emerging challenges for an ageing population. Immunology. 2007 Apr;120(4):435-46. Epub 2007 Feb 15. Review. — View Citation

Ebeling PR. Clinical practice. Osteoporosis in men. N Engl J Med. 2008 Apr 3;358(14):1474-82. doi: 10.1056/NEJMcp0707217. Review. — View Citation

Usui Y, Matsuzaki S, Matsushita K, Shima M. Urolithiasis in geriatric patients. Tokai J Exp Clin Med. 2003 Jul;28(2):81-7. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hypocitraturia is the main metabolic disturbance in aging men with urinary lithiasis	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.	Two years	No