How Bone is Made in Children Receiving Dialysis

NCT ID: NCT01799317

Last Updated: 2013-02-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2014-06-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Vitamin D2

Intervention Type: DRUG

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

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Vitamin D2

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

Intervention Type: DRUG

Other Intervention Names

Ergocalciferol

Eligibility 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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Hospital Los Angeles

OTHER

Sponsor Role: collaborator

Loma Linda University

OTHER

Sponsor Role: collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Isidro Salusky, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Isidro Salusky, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

Loma Linda University

Loma Linda, California, United States

Site Status: RECRUITING

Childrens Hospital Los Angeles

Los Angeles, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Isidro Salusky, MD

Role: CONTACT

isalusky@mednet.ucla.edu

310.206.6987

Facility Contacts

Shobbha Sahney, MD

Role: primary

ssahney@llu.edu

909-558-8242

Kevin Lemley, MD

Role: primary

klemley@chla.usc.edu

323-361-2295

Other Identifiers

R01DK035423-19

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IBS-05

Identifier Type: -

Identifier Source: org_study_id