How Bone is Made in Children Receiving Dialysis

Overview

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.

Full Title of Study: “Regulation of Bone Mineralization in Renal Osteodystrophy”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Factorial Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2014

Interventions

  • Drug: Vitamin D2
    • These patients will receive standard of care vitamin D 1,25 therapy with intervention of vitamin D2

Arms, Groups and Cohorts

  • Active Comparator: Treatment with vitamin D2
    • Vitamin D2 50,000u titrated to serum 25(OH)D values given orally once a month in addition to standard of care: Doxercalciferol escalating doses beginning at 2.5 mcg given orally thrice weekly. Sevelamer Carbonate 800 mg (1600- 4800 mg) given orally with each meal
  • No Intervention: Standard of Care
    • Standard of Care: Doxercalciferol escalating doses beginning at 2.5 mcg given orally thrice weekly. Sevelamer Carbonate 800 mg (1600- 4800 mg) given orally with each meal

Clinical Trial Outcome Measures

Primary Measures

  • Improvement of bone mineralization defect demonstrated by bone histomorphometry
    • Time Frame: 8 months
    • Iliac crest bone biopsy pre and post treatment with vitamin D2

Secondary Measures

  • Radiographic improvement of skeletal abnormalities associated with renal osteodystrophy
    • Time Frame: 8 months
    • We will compare skeletal lesions identified through radiographic studies with bone histomorphometry pre and post treatment with vitamin D2

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 6 Years

Maximum Age: 21 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of California, Los Angeles
  • Collaborator
    • Children’s Hospital Los Angeles
  • Provider of Information About this Clinical Study
    • Principal Investigator: Isidro Salusky, MD, Principal Investigator – University of California, Los Angeles
  • Overall Official(s)
    • Isidro Salusky, MD, Principal Investigator, University of California, Los Angeles
  • Overall Contact(s)
    • Isidro Salusky, MD, 310.206.6987, isalusky@mednet.ucla.edu

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