How Bone is Made in Children Receiving Dialysis

NCT01799317 | Unknown Phase 4 DMC

• 2 other identifiers: IBS-05R01DK035423-19
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Bone Mineralization Defect

Outcome Measures

Primary Outcomes (1)

• Improvement of bone mineralization defect demonstrated by bone histomorphometry

  Iliac crest bone biopsy pre and post treatment with vitamin D2

  8 months

Secondary Outcomes (1)

• Radiographic improvement of skeletal abnormalities associated with renal osteodystrophy

  8 months

Study Arms (2)

Treatment with vitamin D2

ACTIVE COMPARATOR

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

Standard of Care

NO INTERVENTION

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

Interventions

Vitamin D2 DRUG

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

Also known as: Ergocalciferol

Treatment with vitamin D2

Eligibility Criteria

• Age: 6 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• medically stable patients
• years old
• undergoing treatment with continuous cycling peritoneal dialysis
• evidence of mineralization defect and secondary hyperparathyroidism

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Los Angeles: lead
• Children's Hospital Los Angeles: collaborator
• Loma Linda University: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (2)

Loma Linda University

Loma Linda, California, 92354, United States

RECRUITING

Childrens Hospital Los Angeles

Los Angeles, California, 90027, United States

RECRUITING

MeSH Terms

Interventions

Ergocalciferols

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Isidro Salusky, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Isidro Salusky, MD

CONTACT

310.206.6987; isalusky@mednet.ucla.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 20, 2013
• First Posted: February 26, 2013
• Study Start: March 1, 2009
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: February 26, 2013

Record last verified: 2013-02

Locations

US (2)