Hypercalciuria and Calcium Stone Disease in Caucasian Patients

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ClinicalTrials.gov Identifier: NCT00765531

Recruitment Status : Available

First Posted : October 3, 2008

Last Update Posted : October 31, 2008

Sponsor:

Information provided by:

University of Texas Southwestern Medical Center

Study Description

Brief Summary:

The hypothesis of this study proposal is that pediatric urinary stone formers have genetic risk factors which predispose their urinary stone production. 50-60% of pediatric stone patients have a positive family history of urinary stone disease. Several genetic mutations have been identified which predispose patients to various types of urinary stones. These genetic mutations can also lead to other significant sequela besides stones, including osteopenia/osteoporosis (bone loss). Furthermore, metabolic abnormalities can be identified in more than 50% of pediatric stone formers, some of which can be improved/alleviated with medical intervention to help decrease rate of stone formation and the need for hospitalization and surgical intervention.

Condition or disease	Intervention/treatment
Hypercalciuria Calcium Stone Disease	Radiation: Radiological testing Genetic: Pediatric Urologic DNA and History Repository

Study Design


Study Type :	Expanded Access
Official Title:	Hypercalciuria and Calcium Stone Disease in Caucasian Patients

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Calcium

U.S. FDA Resources

Interventions

Intervention Details:

Bone mineral density

All Stone Forming Patients and their families will undergo one of three groups of testing:

Testing 1 - This testing form involves using a specimen from the Pediatric Urologic Blood, Tissue, Urine, Serum, and DNA Repository.

Testing 2 - Involves complete in-patient evaluation at UT Southwestern GCRC for patients with hypercalciuria and their families.

Testing 3 - Involves simple out-patient evaluation for patients with hypercalciuria and their family members.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	4 Years to 20 Years (Child, Adult)
Sexes Eligible for Study:	All

Criteria

Inclusion Criteria:

Male and female English-speaking Caucasian patients >4 years of age with a history of stone formation before age 20 years, their family members, and sex- and age-matched pediatric normal volunteers will be included regardless of current age, gender, race or ethnicity.

Exclusion Criteria:

Patients will be excluded with voiding dysfunction or metabolic disorders including renal tubular acidosis, chronic renal insufficiency, intestinal malabsorption (inflammatory bowel disease, history of ileal resection or bladder augmentation, and cystic fibrosis), hyperparathyroidism, prolonged immobilization, vitamin D excess, hpercalcemia, hypophosphatasia, Bartter's syndrome, high dose steroid therapy, prematurity, and chronic lasix use. Any child with a bleeding diathesis or who is immunocompromised will be excluded given the increased risks of drawing blood. Participants who have been on anti-seizure medication such as Topamax or other lithogenic drugs and anti-seizure medication will be excluded. Non-English speaking subjects are not eligible to participate in the study, as this study specifically focuses on English-speaking Caucasian patients based on the adult study from which this study project has been derived.

Contacts and Locations

Information from the National Library of Medicine

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): NCT00765531

Contacts


Contact: Linda A. Baker, MD	214-456-2467	Linda.Baker@UTSouthwestern.edu

Sponsors and Collaborators

University of Texas Southwestern Medical Center

More Information


Responsible Party:	Linda A. Baker, M.D., University of Texas Southwestern Medical School
ClinicalTrials.gov Identifier:	NCT00765531 History of Changes
Other Study ID Numbers:	1101-577
First Posted:	October 3, 2008 Key Record Dates
Last Update Posted:	October 31, 2008
Last Verified:	October 2008

Keywords provided by University of Texas Southwestern Medical Center:


To determine the prevalence of genetic mutations in a population. To identify stone formers with significant family history of stones. To follow a cohort of pediatric stone formers an their families to report the long-term recurrence rats and therapeutic outcomes.

Additional relevant MeSH terms:


Calculi Hypercalciuria Pathological Conditions, Anatomical Urological Manifestations Signs and Symptoms

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