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
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