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How Bone is Made in Children Receiving Dialysis

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2013 by Isidro Salusky, MD, University of California, Los Angeles.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01799317
First Posted: February 26, 2013
Last Update Posted: February 26, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
  Purpose
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.

Condition Intervention Phase
Bone Mineralization Defect Drug: Vitamin D2 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Regulation of Bone Mineralization in Renal Osteodystrophy

Resource links provided by NLM:


Further study details as provided by Isidro Salusky, MD, University of California, Los Angeles:

Primary Outcome 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 Outcome 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


Estimated Enrollment: 60
Study Start Date: March 2009
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Drug: Vitamin D2
These patients will receive standard of care vitamin D 1,25 therapy with intervention of vitamin D2
Other Name: Ergocalciferol
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01799317


Contacts
Contact: Isidro Salusky, MD 310.206.6987 isalusky@mednet.ucla.edu

Locations
United States, California
Loma Linda University Recruiting
Loma Linda, California, United States, 92354
Contact: Shobbha Sahney, MD    909-558-8242    ssahney@llu.edu   
Principal Investigator: Shobha Sahney, MD         
Childrens Hospital Los Angeles Recruiting
Los Angeles, California, United States, 90027
Contact: Kevin Lemley, MD    323-361-2295    klemley@chla.usc.edu   
Principal Investigator: Kevin Lemley, MD         
Sponsors and Collaborators
University of California, Los Angeles
Children's Hospital Los Angeles
Loma Linda University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Isidro Salusky, MD University of California, Los Angeles
  More Information

Responsible Party: Isidro Salusky, MD, Principal Investigator, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01799317     History of Changes
Other Study ID Numbers: IBS-05
R01DK035423-19 ( U.S. NIH Grant/Contract )
First Submitted: February 20, 2013
First Posted: February 26, 2013
Last Update Posted: February 26, 2013
Last Verified: February 2013

Additional relevant MeSH terms:
Calcinosis
Calcium Metabolism Disorders
Metabolic Diseases
Vitamins
Vitamin D
Ergocalciferols
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents