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

Calcium Nephrolithiasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00416052
• Other study ID #: BE001
• Status: Completed
• Phase: N/A
• First received: December 26, 2006
• Last updated: May 18, 2011
• Start date: March 2004
• Est. completion date: June 2006

Study information

• Verified date: May 2011
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only

Related Conditions & MeSH terms

• Calcium Nephrolithiasis
• Nephrolithiasis

Locations

Country	Name	City	State
Switzerland	Dept. Nephrology & Hypertension, Univ. Hospital Bern	Bern

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland,