Calcitriol |
Rocaltrol |
Clinical Trial: Phase II Randomized Study of the Effects of Growth Hormone on Children and Adolescents on Maintenance Dialysis
This study has been completed.
Purpose
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.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Renal Osteodystrophy End Stage Renal Disease | Drug: calcitriol Drug: growth hormone | Phase II |
MedlinePlus related topics: Kidney Diseases; Kidney Failure; Parathyroid Disorders
Study Type: Interventional
Study Design: Treatment, Randomized
Expected Total Enrollment: 109
Study start: June 1995
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.
Eligibility
Ages Eligible for Study: 1 Year - 18 Years, Genders Eligible for Study: Both
Criteria
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
- End-stage renal disease undergoing continuous cycling peritoneal dialysis at the University of California at Los Angeles
--Prior/Concurrent Therapy--
- No concurrent prednisone
- No concurrent cytotoxic agents
- At least 12 months since parathyroidectomy
--Patient Characteristics--
- Other: No documented history of poor compliance with medical treatment regimens
Location Information
California
University of California Los Angeles School of Medicine, Los Angeles, California, 90095, United States
Isidro B. Salusky, Study Chair, University of California, Los Angeles
More Information
Record last reviewed: April 2002
Last Updated: October 13, 2004
Record first received: October 18, 1999
ClinicalTrials.gov Identifier: NCT00004340
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
Resources
- Calcitriol (Drug Digest)
- Rocaltrol (Drug Digest)

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