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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

Tracking Information
First Submitted Date  ICMJE February 20, 2013
First Posted Date  ICMJE February 26, 2013
Last Update Posted Date February 26, 2013
Study Start Date  ICMJE March 2009
Estimated Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 22, 2013)
Improvement of bone mineralization defect demonstrated by bone histomorphometry [ Time Frame: 8 months ]
Iliac crest bone biopsy pre and post treatment with vitamin D2
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 22, 2013)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE How Bone is Made in Children Receiving Dialysis
Official Title  ICMJE Regulation of Bone Mineralization in Renal Osteodystrophy
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Bone Mineralization Defect
Intervention  ICMJE Drug: Vitamin D2
These patients will receive standard of care vitamin D 1,25 therapy with intervention of vitamin D2
Other Name: Ergocalciferol
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 22, 2013)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2014
Estimated Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 21 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01799317
Other Study ID Numbers  ICMJE IBS-05
R01DK035423-19 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Isidro Salusky, MD, University of California, Los Angeles
Study Sponsor  ICMJE University of California, Los Angeles
Collaborators  ICMJE
  • Children's Hospital Los Angeles
  • Loma Linda University
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators  ICMJE
Principal Investigator: Isidro Salusky, MD University of California, Los Angeles
PRS Account University of California, Los Angeles
Verification Date February 2013

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