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How Bone is Made in Children Receiving Dialysis

Information source: University of California, Los Angeles
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Bone Mineralization Defect

Intervention: Vitamin D2 (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: University of California, Los Angeles

Official(s) and/or principal investigator(s):
Isidro Salusky, MD, Principal Investigator, Affiliation: University of California, Los Angeles

Overall contact:
Isidro Salusky, MD, Phone: 310.206.6987, Email: isalusky@mednet.ucla.edu

Summary

The study outlined is designed to measure and to determine whether the combined use of vitamin D2 (ergocalciferoI) and 1-alpha-hydroxyvitamin D2 (doxercalciferol)) or doxercalciferol alone will correct the mineralization defect in pediatric patients with established secondary hyperparathyroidism (2°HPT) undergoing regular peritoneal dialysis. Serum phosphorus levels will be controlled with a calcium¬-free-metal free phosphate binder; (obtained at baseline and after 8 months of treatment) sevelamer. Indices of bone mineralization obtained at baseline and after 8 months of treatment will be measured by quantitative histomorphometry in iliac crest bone biopsies after double tetracycline labeling. Immunohistochemistry will be done in specimens of bone biopsies from iliac crest to examine the expression for selected markers of bone turnover and mineralization such as FGF-23, DMP1, MEPE and OPG. Serum PTH levels will be measured with the 1st and 2nd generation immunometric assay (PTH-IMAs) and fibroblast growth factor-23 (FGF-23) will be determined by one assay with specific detection antibodies that are against epitopes within the C-terminus of FGF-23 and another assay that uses antibodies against epitopes within the N- and C-terminal portions of the molecule respectively. The value of non-invasive assessment of bone mass by quantitative computed tomography (QCT) and its relationship with vascular disease determined by ultrasound (US) of intimal carotid thickness (CIMT) will be correlated with bone histomorphometry and the different biochemical determinations.

Clinical Details

Official title: Regulation of Bone Mineralization in Renal Osteodystrophy

Study design: Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Improvement of bone mineralization defect demonstrated by bone histomorphometry

Secondary outcome: Radiographic improvement of skeletal abnormalities associated with renal osteodystrophy

Eligibility

Minimum age: 6 Years. Maximum age: 21 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- medically stable patients

- 6-21 years old

- undergoing treatment with continuous cycling peritoneal dialysis

- evidence of mineralization defect and secondary hyperparathyroidism

Exclusion Criteria:

- histopathological lesion of bone such as adynamic bone or osteomalacia

- poor compliance

- current treatment with prednisone or other immunosuppressives

- treatment with human recombinant growth hormone

- parathyroidectomy

Locations and Contacts

Isidro Salusky, MD, Phone: 310.206.6987, Email: isalusky@mednet.ucla.edu

Loma Linda University, Loma Linda, California 92354, United States; Recruiting
Shobbha Sahney, MD, Phone: 909-558-8242, Email: ssahney@llu.edu
Shobha Sahney, MD, Principal Investigator

Childrens Hospital Los Angeles, Los Angeles, California 90027, United States; Recruiting
Kevin Lemley, MD, Phone: 323-361-2295, Email: klemley@chla.usc.edu
Kevin Lemley, MD, Principal Investigator

Additional Information

Starting date: March 2009
Last updated: February 22, 2013

Page last updated: August 23, 2015

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