Relation Between Bone Density and the Regulation of Mineral Metabolism in Renal Stone Formers
| Tracking Information | |||||
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| First Received Date ICMJE | December 26, 2006 | ||||
| Last Updated Date | May 18, 2011 | ||||
| Start Date ICMJE | March 2004 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00416052 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Relation Between Bone Density and the Regulation of Mineral Metabolism in Renal Stone Formers | ||||
| Official Title ICMJE | Relation Between Bone Mineral Density and the Regulation of Mineral Metabolism in Renal Stone Formers | ||||
| 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. |
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| 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case-Only | ||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Recurrent renal calcium stone formers |
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| Condition ICMJE | Calcium Nephrolithiasis | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 90 | ||||
| Completion Date | June 2006 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Switzerland | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00416052 | ||||
| Other Study ID Numbers ICMJE | BE001 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Andreas Pasch, Department of Nephrology and Hypertension, Inselspital, University Hospital Bern | ||||
| Study Sponsor ICMJE | University Hospital Inselspital, Berne | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University Hospital Inselspital, Berne | ||||
| Verification Date | May 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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