Calcium NephrolithiasisNCT00416052
Relation Between Bone Density and the Regulation of Mineral Metabolism in Renal Stone Formers
An observational study of Calcium Nephrolithiasis, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Calcium Nephrolithiasis
- How many people
- 90 participants
- Where
- 1 siteSwitzerland
- Study dates
- Mar 2004to Jun 2006
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Recurrent renal calcium stone formers
Who may be able to join
- passage of at least one calcium containing kidney stone
Who cannot join
- established cause of calcium stone formation (sarcoidosis, primary hyperparathyroidism etc.)
- creatinine clearance < 60 ml/min
- urinary tract infection
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Dept. Nephrology & Hypertension, Univ. Hospital Bern
Bern, 3010
About this study
Official title: Relation Between Bone Mineral Density and the Regulation of Mineral Metabolism in Renal Stone Formers
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.
Read the 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.
- Conditions
- Calcium Nephrolithiasis
- Keywords
- calcium, calciuria, PTH, 1,25-vitamin D, Calcitriol, bone mineral density, osteodensitometry
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2006 (estimated)
- Study startMar 2004
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Calcium NephrolithiasisStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe 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 only
- Enrolment
- 90 participants
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Investigators
- Felix J Frey, MD, Study director, University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00416052
- Sponsor's protocol ID
- BE001
- Status last verified
- May 2011
- First submitted
- 26 Dec 2006
- Last updated
- 19 May 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relation Between Bone Mineral Density and the Regulation of Mineral Metabolism in Renal Stone Formers
- ClinicalTrials.gov ID
- NCT00416052
- Acronym / sponsor ID
- BE001
- Conditions
- Calcium Nephrolithiasis
- Keywords
- calcium, calciuria, PTH, 1,25-vitamin D, Calcitriol, bone mineral density, osteodensitometry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- Mar 2004
- Study completion
- Jun 2006
- First posted
- 27 Dec 2006 (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.
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
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
- Observational model
- Case only
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Recurrent renal calcium stone formers
Key inclusion criteria (1 listed)
- passage of at least one calcium containing kidney stone
Key exclusion criteria (3 listed)
- established cause of calcium stone formation (sarcoidosis, primary hyperparathyroidism etc.)
- creatinine clearance < 60 ml/min
- urinary tract infection
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
Not reported in the source record.
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 19 May 2011.
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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.
Felix J Frey, MD study director
University of Bern
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 Calcium Nephrolithiasis, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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 1 inclusion and 3 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 19 May 2011. 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 Switzerland. 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.
Where can I read the original study information?
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 19 May 2011.