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Relation Between Bone Density and the Regulation of Mineral Metabolism in Renal Stone Formers

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ClinicalTrials.gov Identifier: NCT00416052
Recruitment Status : Completed
First Posted : December 27, 2006
Last Update Posted : May 19, 2011
Sponsor:
Information provided by:

Study Description
Brief Summary:
Accumulating evidence indicated that renal calcium stone formers often exhibit a low bone density. Therefore we want to test the hypothesis, that the mineral (calcium) metabolism is differently regulated in calcium stone formers with low as opposed to high bone density.

Condition or disease
Calcium Nephrolithiasis

Detailed Description:

There is epidemiological evidence associating renal calcium stones and decreased bone mineral density (BMD). The decreased BMD in calcium stone formers is linked to hypercalciuria and both subtypes, fasting as well as absorptive hypercalciuria are associated with a diminished BMD. Higher 1,25-vitamin D plasma concentrations and lower PTH levels are encountered under free-choice diet conditions in patients diagnosed with absorptive and fasting hypercalciuria when compared to normocalciuric stone formers. Reports studying the BMD of stone formers and its link with mineral metabolism variables and urinary calcium excretion under different calcium intakes are rare.

We hypothesize now that PTH and 1,25-vitamin D change differently when calcium stone formers with high, intermediate and low BMD are challenged by a low calcium diet.


Study Design

Study Type : Observational
Estimated Enrollment : 90 participants
Observational Model: Case-Only
Official Title: Relation Between Bone Mineral Density and the Regulation of Mineral Metabolism in Renal Stone Formers
Study Start Date : March 2004
Estimated Study Completion Date : June 2006

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U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Recurrent renal calcium stone formers
Criteria

Inclusion Criteria:

  • passage of at least one calcium containing kidney stone

Exclusion Criteria:

  • established cause of calcium stone formation (sarcoidosis, primary hyperparathyroidism etc.)
  • creatinine clearance < 60 ml/min
  • urinary tract infection
Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00416052


Locations
Switzerland
Dept. Nephrology & Hypertension, Univ. Hospital Bern
Bern, Switzerland, 3010
Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
Study Director: Felix J Frey, MD University of Bern
More Information

Responsible Party: Andreas Pasch, Department of Nephrology and Hypertension, Inselspital, University Hospital Bern
ClinicalTrials.gov Identifier: NCT00416052     History of Changes
Other Study ID Numbers: BE001
First Posted: December 27, 2006    Key Record Dates
Last Update Posted: May 19, 2011
Last Verified: May 2011

Keywords provided by University Hospital Inselspital, Berne:
calcium
calciuria
PTH
1,25-vitamin D
Calcitriol
bone mineral density
osteodensitometry

Additional relevant MeSH terms:
Nephrolithiasis
Kidney Calculi
Kidney Diseases
Urologic Diseases
Urolithiasis
Urinary Calculi
Calculi
Pathological Conditions, Anatomical