Metabolic Assessment of Aging Men With Urinary Lithiasis

This study has been completed.
Sponsor:
Information provided by:
University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier:
NCT01246531
First received: November 22, 2010
Last updated: NA
Last verified: October 2010
History: No changes posted
  Purpose

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.


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

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Clinical Investigation of Aging Men With Renal Stones: The Role of Bone Demineralization (Metabolic and Hormonal Assessment)

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo General Hospital:

Primary Outcome Measures:
  • Hypocitraturia is the main metabolic disturbance in aging men with urinary lithiasis [ Time Frame: Two years ] [ Designated as safety issue: No ]
    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.


Enrollment: 42
Study Start Date: January 2008
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Urolithiasis
Case arm: men above fifty years-old with urolithiasis
Control
Control arm: men above fifty years-old without urolithiasis

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

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01246531

Locations
Brazil
University of São Paulo General Hospital
São Paulo, Brazil, 05403010
Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
Principal Investigator: Eduardo Mazzucchi, MD University of São Paulo General Hospital - Division of Urology
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Eduardo Mazzucchi, University of São Paulo General Hospital
ClinicalTrials.gov Identifier: NCT01246531     History of Changes
Other Study ID Numbers: 0688/07
Study First Received: November 22, 2010
Last Updated: November 22, 2010
Health Authority: Brazil: Ethics Committee

Keywords provided by University of Sao Paulo General Hospital:
Urolithiasis
Renal calculi
Aging
Osteoporosis

Additional relevant MeSH terms:
Metabolic Diseases
Osteoporosis
Urolithiasis
Bone Diseases
Bone Diseases, Metabolic
Musculoskeletal Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on October 23, 2014