How Bone is Made in Children Receiving Dialysis
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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: Open Label Primary Purpose: Treatment |
| Official Title: | Regulation of Bone Mineralization in Renal Osteodystrophy |
- Improvement of bone mineralization defect demonstrated by bone histomorphometry [ Time Frame: 8 months ] [ Designated as safety issue: No ]Iliac crest bone biopsy pre and post treatment with vitamin D2
- Radiographic improvement of skeletal abnormalities associated with renal osteodystrophy [ Time Frame: 8 months ] [ Designated as safety issue: No ]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| Ages Eligible for Study: | 6 Years to 21 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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| Contact: Isidro Salusky, MD | 310.206.6987 | isalusky@mednet.ucla.edu |
| 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 | |
| Principal Investigator: | Isidro Salusky, MD | University of California, Los Angeles |
More Information
No publications provided
| 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 |
| Study First Received: | February 20, 2013 |
| Last Updated: | February 22, 2013 |
| Health Authority: | United States: National Institute of Health |
Additional relevant MeSH terms:
|
Renal Osteodystrophy Calcinosis Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases Rickets Kidney Diseases Urologic Diseases Calcium Metabolism Disorders Metabolic Diseases Vitamin D Deficiency Avitaminosis Deficiency Diseases Malnutrition |
Nutrition Disorders Hyperparathyroidism, Secondary Hyperparathyroidism Parathyroid Diseases Endocrine System Diseases Ergocalciferols Vitamin D Vitamins Bone Density Conservation Agents Physiological Effects of Drugs Pharmacologic Actions Micronutrients Growth Substances |
ClinicalTrials.gov processed this record on May 16, 2013