Urolithiasis and AgingNCT01246531
Metabolic Assessment of Aging Men With Urinary Lithiasis
An observational study of Urolithiasis and Aging and Renal Calcul and Metabolic Diseases, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 50 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Urolithiasis and Aging, Renal Calcul and Metabolic Diseases, Urolithiasis and Osteoporosis
- How many people
- 42 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2008to Jan 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Men above fifty years-old with urolithiasis diagnosis (case arm)
- Men above fifty years-old without urolithiasis diagnosis (control arm)
Who cannot join
- Urolithiasis diagnosis (clinical or incidental) before fifty years-old.
- Urinary culture positive
Trial locations and contacts
1 site in 1 country.
Brazil1 site
University of São Paulo General Hospital
São Paulo, São Paulo, 05403010
About this study
Official title: Clinical Investigation of Aging Men With Renal Stones: The Role of Bone Demineralization (Metabolic and Hormonal Assessment)
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.
Read the 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.
- Conditions
- Urolithiasis and Aging, Renal Calcul and Metabolic Diseases, Urolithiasis and Osteoporosis
- Keywords
- Urolithiasis, Renal calculi, Aging, Osteoporosis
- Medical subject headings
- Urolithiasis, Metabolic Diseases, Osteoporosis, Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Urolithiasis | Case arm: men above fifty years-old with urolithiasis | |
| Control | Control arm: men above fifty years-old without urolithiasis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2010 (estimated)
- Study startJan 2008
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Urolithiasis and AgingStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Eduardo Mazzucchi, MD, Principal investigator, University of São Paulo General Hospital - Division of Urology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01246531
- Sponsor's protocol ID
- 0688/07
- Status last verified
- Oct 2010
- First submitted
- 22 Nov 2010
- Last updated
- 23 Nov 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Usui Y, Matsuzaki S, Matsushita K, Shima M. Urolithiasis in geriatric patients. Tokai J Exp Clin Med. 2003 Jul;28(2):81-7.
PubMed 14714833Vella 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.
PubMed 17726349Ebeling PR. Clinical practice. Osteoporosis in men. N Engl J Med. 2008 Apr 3;358(14):1474-82. doi: 10.1056/NEJMcp0707217. No abstract available.
PubMed 18385499Aw 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.
PubMed 17313487Freitas 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.
PubMed 22666789
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigation of Aging Men With Renal Stones: The Role of Bone Demineralization (Metabolic and Hormonal Assessment)
- ClinicalTrials.gov ID
- NCT01246531
- Acronym / sponsor ID
- 0688/07
- Conditions
- Urolithiasis and Aging, Renal Calcul and Metabolic Diseases, Urolithiasis and Osteoporosis
- Keywords
- Urolithiasis, Renal calculi, Aging, Osteoporosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 23 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Urolithiasis | – | –Case arm: men above fifty years-old with urolithiasis |
| Control | – | –Control arm: men above fifty years-old without urolithiasis |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Men above fifty years-old with urolithiasis diagnosis (case arm)
- Men above fifty years-old without urolithiasis diagnosis (control arm)
Key exclusion criteria (2 listed)
- Urolithiasis diagnosis (clinical or incidental) before fifty years-old.
- Urinary culture positive
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2010.
- Background: PubMed 14714833Usui Y, Matsuzaki S, Matsushita K, Shima M. Urolithiasis in geriatric patients. Tokai J Exp Clin Med. 2003 Jul;28(2):81-7.
- Background: PubMed 17726349Vella 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.
- Background: PubMed 18385499Ebeling PR. Clinical practice. Osteoporosis in men. N Engl J Med. 2008 Apr 3;358(14):1474-82. doi: 10.1056/NEJMcp0707217. No abstract available.
- Background: PubMed 17313487Aw 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.
- Derived from this study: PubMed 22666789Freitas 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eduardo Mazzucchi, MD principal investigator
University of São Paulo General Hospital - Division of Urology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urolithiasis and Aging and Renal Calcul and Metabolic Diseases, run by University of Sao Paulo General Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hypocitraturia is the main metabolic disturbance in aging men with urinary lithiasis (time frame: Two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01246531, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2010.