Phase II Randomized Study of the Effects of Growth Hormone on Children and Adolescents on Maintenance Dialysis
Summary
OBJECTIVES: I. Evaluate the separate and combined skeletal effects of recombinant human growth hormone (GH) and calcitriol in patients with adynamic renal osteodystrophy.
II. Assess whether calcium-regulated changes in parathyroid hormone secretion predict changes in bone formation.
III. Characterize the response to GH in cancellous bone and in growth plate cartilage in patients with secondary hyperparathyroidism during calcitriol therapy.
Description
PROTOCOL OUTLINE: This is a randomized study. Patients are stratified by bone lesion turnover and secondary hyperparathyroidism.
Patients in the first group are treated with recombinant human growth hormone subcutaneously every day for 8 months.
Patients in the second group are treated with calcitriol for 8 months, administered as a daily oral dose or an intraperitoneal dose three times a week.
Patients in the third group are treated with growth hormone and calcitriol (same dosages as above).
A control group does not receive any hormonal therapy.
Study Design
Allocation: Randomized, Primary Purpose: Treatment
Conditions
Renal Osteodystrophy
Intervention
calcitriol, growth hormone
Location
University of California Los Angeles School of Medicine
Los Angeles
California
United States
90095
Status
Completed
Source
National Center for Research Resources (NCRR)
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00004340
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Calcitriol
The physiologically active form of vitamin D. It is formed primarily in the kidney by enzymatic hydroxylation of 25-hydroxycholecalciferol (CALCIFEDIOL). Its production is stimulated by low blood calcium levels and parathyroid hormone. Calcitriol increases intestinal absorption of calcium and phosphorus, and in concert with parathyroid hormone increases bone resorption.
Hyperparathyroidism, Secondary
Abnormally elevated PARATHYROID HORMONE secretion as a response to HYPOCALCEMIA. It is caused by chronic KIDNEY FAILURE or other abnormalities in the controls of bone and mineral metabolism, leading to various BONE DISEASES, such as RENAL OSTEODYSTROPHY.
Renal Osteodystrophy
Decalcification of bone or abnormal bone development due to chronic KIDNEY DISEASES, in which 1,25-DIHYDROXYVITAMIN D3 synthesis by the kidneys is impaired, leading to reduced negative feedback on PARATHYROID HORMONE. The resulting SECONDARY HYPERPARATHYROIDISM eventually leads to bone disorders.
Human Growth Hormone
A 191-amino acid polypeptide hormone secreted by the human adenohypophysis (PITUITARY GLAND, ANTERIOR), also known as GH or somatotropin. Synthetic growth hormone, termed somatropin, has replaced the natural form in therapeutic usage such as treatment of dwarfism in children with growth hormone deficiency.
Growth Hormone-secreting Pituitary Adenoma
A pituitary tumor that secretes GROWTH HORMONE. In humans, excess HUMAN GROWTH HORMONE leads to ACROMEGALY.
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