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How Bone is Made in Children Receiving Dialysis

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ClinicalTrials.gov Identifier: NCT01799317
Recruitment Status : Unknown
Verified February 2013 by Isidro Salusky, MD, University of California, Los Angeles.
Recruitment status was:  Recruiting
First Posted : February 26, 2013
Last Update Posted : February 26, 2013
Sponsor:
Collaborators:
Children's Hospital Los Angeles
Loma Linda University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Isidro Salusky, MD, University of California, Los Angeles

February 20, 2013
February 26, 2013
February 26, 2013
March 2009
June 2014   (Final data collection date for primary outcome measure)
Improvement of bone mineralization defect demonstrated by bone histomorphometry [ Time Frame: 8 months ]
Iliac crest bone biopsy pre and post treatment with vitamin D2
Same as current
No Changes Posted
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
Same as current
Not Provided
Not Provided
 
How Bone is Made in Children Receiving Dialysis
Regulation of Bone Mineralization in Renal Osteodystrophy
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Bone Mineralization Defect
Drug: Vitamin D2
These patients will receive standard of care vitamin D 1,25 therapy with intervention of vitamin D2
Other Name: Ergocalciferol
  • 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
    Intervention: Drug: Vitamin D2
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
60
Same as current
June 2014
June 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
6 Years to 21 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01799317
IBS-05
R01DK035423-19 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Not Provided
Isidro Salusky, MD, University of California, Los Angeles
University of California, Los Angeles
  • Children's Hospital Los Angeles
  • Loma Linda University
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Isidro Salusky, MD University of California, Los Angeles
University of California, Los Angeles
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP