Recruiting

Observational Study

Sponsor:

UCLA

Code:

NCT01799317

Conditions

Bone Mineralization Defect

Eligibility Criteria

Sex: All

Age: 6 - 21

Healthy Volunteers: Not accepted

Interventions

Vitamin D2

Study Details

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 ID

NCT01799317

Start date

Mar, 2009

Status verified date

Feb, 2013

Completion date

Jun, 2014

Anticipated

Primary completion date

Jun, 2014

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 21

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

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

Interventions

Vitamin D2

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

Primary outcome measure

  • Improvement of bone mineralization defect demonstrated by bone histomorphometry [ Time Frame: 8 months ]

Central Contacts and Locations

Central contacts

Isidro Salusky, MD

310.206.6987isalusky@mednet.ucla.edu

Locations

Loma Linda University

Recruiting

Loma Linda, California, United States, 92354

Contacts

Shobbha Sahney, MD

909-558-8242ssahney@llu.edu

Principal Investigator:

Shobha Sahney, MD

Childrens Hospital Los Angeles

Recruiting

Los Angeles, California, United States, 90027

Contacts

Kevin Lemley, MD

323-361-2295klemley@chla.usc.edu

Principal Investigator:

Kevin Lemley, MD

More Information

Sponsor

University of California, Los Angeles

Last update posted

Feb 26, 2013

Last verified

Feb, 2013

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of California, Los Angeles on 2013-02-26.