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Metabolic Assessment of Aging Men With Urinary Lithiasis

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ClinicalTrials.gov Identifier: NCT01246531
Recruitment Status : Completed
First Posted : November 23, 2010
Last Update Posted : November 23, 2010
Sponsor:
Information provided by:
University of Sao Paulo General Hospital

Tracking Information
First Submitted Date November 22, 2010
First Posted Date November 23, 2010
Last Update Posted Date November 23, 2010
Study Start Date January 2008
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 22, 2010)
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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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)
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.

Study Type Observational
Study Design Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Urolithiasis and Aging
  • Renal Calcul and Metabolic Diseases
  • Urolithiasis and Osteoporosis
Intervention Not Provided
Study Groups/Cohorts
  • Urolithiasis
    Case arm: men above fifty years-old with urolithiasis
  • Control
    Control arm: men above fifty years-old without urolithiasis
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 22, 2010)
42
Original Actual Enrollment Same as current
Actual Study Completion Date January 2010
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: Male
Ages 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Brazil
Removed Location Countries  
 
Administrative Information
NCT Number NCT01246531
Other Study ID Numbers 0688/07
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Eduardo Mazzucchi, University of São Paulo General Hospital
Study Sponsor University of Sao Paulo General Hospital
Collaborators Not Provided
Investigators
Principal Investigator: Eduardo Mazzucchi, MD University of São Paulo General Hospital - Division of Urology
PRS Account University of Sao Paulo General Hospital
Verification Date October 2010