Phase II Randomized Study of the Effects of Growth Hormone on Children and Adolescents on Maintenance Dialysis

NCT00004340 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 109

Last updated 2005-06-24

No results posted yet for this study

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.

Conditions

Interventions

DRUG

calcitriol

DRUG

growth hormone

Sponsors & Collaborators

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

    collaborator NIH
  • University of California, Los Angeles

    collaborator OTHER
  • National Center for Research Resources (NCRR)

    lead NIH

Principal Investigators

  • Isidro B. Salusky · University of California, Los Angeles

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT

Eligibility

Min Age
1 Year
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1995-06-30

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00004340 on ClinicalTrials.gov