Phase II Randomized Study of the Effects of Growth Hormone on Children and Adolescents on Maintenance Dialysis - Full Text View

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

This study has been completed.

Sponsors and Collaborators:	National Center for Research Resources (NCRR) National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) University of California, Los Angeles
Information provided by:	National Center for Research Resources (NCRR)
ClinicalTrials.gov Identifier:	NCT00004340

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 II

Drug Information available for:

Calcitriol Somatotropin Somatropin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized

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

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

National Center for Research Resources (NCRR)

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

University of California, Los Angeles

Investigators


Study Chair:	Isidro B. Salusky	University of California, Los Angeles

More Information

Study ID Numbers:	199/11899, UCLA-612
First Received:	October 18, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00004340
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

Study placed in the following topic categories:

Parathyroid Diseases

Renal Insufficiency

Avitaminosis

Kidney Failure, Chronic

Bone Diseases

Renal rickets

Calcitriol

Hyperparathyroidism, Secondary

Malnutrition

Musculoskeletal Diseases

Urologic Diseases

Neoplasm Metastasis

Nutrition Disorders

Kidney Diseases

Deficiency Diseases

Vitamin D Deficiency

Metabolic Diseases

Renal Osteodystrophy

Rare Diseases

Endocrine System Diseases

Bone Diseases, Metabolic

Hyperparathyroidism

Rickets

Renal Insufficiency, Chronic

Renal osteodystrophy

Endocrinopathy

Metabolic disorder

Kidney Failure

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action

Growth Substances

Physiological Effects of Drugs

Calcium Channel Agonists

Bone Density Conservation Agents

Cardiovascular Agents

Pharmacologic Actions

Calcium Metabolism Disorders

Membrane Transport Modulators

Vitamins

Therapeutic Uses

Vasoconstrictor Agents

Micronutrients

ClinicalTrials.gov processed this record on November 30, 2008