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

NCT ID: NCT00416052

Last Updated: 2011-05-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-03-31

Study Completion Date

2006-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Calcium Nephrolithiasis

Study Design

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Observational Model Type

CASE_ONLY

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role lead

Responsible Party

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Department of Nephrology and Hypertension, Inselspital, University Hospital Bern

Principal Investigators

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Felix J Frey, MD

Role: STUDY_DIRECTOR

University of Bern

Locations

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Dept. Nephrology & Hypertension, Univ. Hospital Bern

Bern, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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BE001

Identifier Type: -

Identifier Source: org_study_id

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