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

This study has been completed.
Sponsor:
Collaborators:
University of California, Los Angeles
Information provided by:
National Center for Research Resources (NCRR)
ClinicalTrials.gov Identifier:
NCT00004340
First received: October 18, 1999
Last updated: June 23, 2005
Last verified: April 2002
  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 Intervention Phase
Renal Osteodystrophy
End Stage Renal Disease
Drug: calcitriol
Drug: growth hormone
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by National Center for Research Resources (NCRR):

Estimated Enrollment: 109
Study Start Date: June 1995
Detailed 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.

  Eligibility

Ages Eligible for Study:   1 Year to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004340

Locations
United States, California
University of California Los Angeles School of Medicine
Los Angeles, California, United States, 90095
Sponsors and Collaborators
University of California, Los Angeles
Investigators
Study Chair: Isidro B. Salusky University of California, Los Angeles
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00004340     History of Changes
Other Study ID Numbers: 199/11899, UCLA-612
Study First Received: October 18, 1999
Last Updated: June 23, 2005
Health Authority: United States: Federal Government

Keywords provided by National Center for Research Resources (NCRR):
end stage renal disease
rare disease
renal and genitourinary disorders
renal osteodystrophy

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Renal Osteodystrophy
Avitaminosis
Bone Diseases
Bone Diseases, Metabolic
Calcium Metabolism Disorders
Deficiency Diseases
Endocrine System Diseases
Hyperparathyroidism
Hyperparathyroidism, Secondary
Malnutrition
Metabolic Diseases
Musculoskeletal Diseases
Nutrition Disorders
Parathyroid Diseases
Renal Insufficiency
Renal Insufficiency, Chronic
Rickets
Urologic Diseases
Vitamin D Deficiency
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 20, 2014