Stone Disease in Children and Their Families
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ClinicalTrials.gov Identifier: NCT00765531 |
Expanded Access Status :
Available
First Posted : October 3, 2008
Last Update Posted : January 17, 2019
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Condition or disease | Intervention/treatment |
---|---|
Hypercalciuria Urolithiasis | Radiation: Radiological testing Genetic: Pediatric Urologic DNA and History Repository |

Study Type : | Expanded Access |
Official Title: | Stone Disease in Children and Their Families |

- Radiation: Radiological testing
Bone mineral density
- Genetic: Pediatric Urologic DNA and History Repository
All Stone Forming Patients and their families will undergo one of two groups of testing:
Testing 1 - Involves completing an in-patient evaluation at UT Southwestern for patients with hypercalciuria and their families.
Testing 2 - Involves completing a simple out-patient evaluation for patients with or without hypercalciuria and their family members.

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Ages Eligible for Study: | 4 Years to 20 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Inclusion Criteria:
- Male and female patients of all races with a history of stone formation before age 20 years, patients with a history of stone formation between the ages of 4 and 19 years will be included regardless of current age or gender, healthy family members (>4 years of age to 75 years) of the probands will be invited to participate in the study and will be characterized as an affected or unaffected patient by the testing, and sex- and age-matched pediatric normal volunteers will also be recruited as controls.
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.

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
Contact: Linda A. Baker, MD | 214-456-2480 | Linda.Baker@UTSouthwestern.edu | |
Contact: Martinez Hill | 214-456-0279 | martinez.hill@childrens.com |
Responsible Party: | Linda A Baker, Professor & Interim Chief of Urology, Director of Pediatric Urology Research, University of Texas Southwestern Medical Center |
ClinicalTrials.gov Identifier: | NCT00765531 History of Changes |
Other Study ID Numbers: |
STU 062011-081 |
First Posted: | October 3, 2008 Key Record Dates |
Last Update Posted: | January 17, 2019 |
Last Verified: | January 2019 |
Determine prevalence of genetic mutations in a population. Identify stone formers w/significant family history. follow a cohort of pediatric stone formers & their families. Report long-term recurrence rates & therapeutic outcomes. |
Urolithiasis Hypercalciuria Urologic Diseases Urological Manifestations Signs and Symptoms |