Phase II Randomized Study of the Effects of Growth Hormone on Children and Adolescents on Maintenance Dialysis
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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 |
| Estimated Enrollment: | 109 |
| Study Start Date: | 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 to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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| United States, California | |
| University of California Los Angeles School of Medicine | |
| Los Angeles, California, United States, 90095 | |
| 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 Urologic Diseases Renal Insufficiency, Chronic Renal Insufficiency Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases Rickets Calcium Metabolism Disorders Metabolic Diseases Vitamin D Deficiency Avitaminosis Deficiency Diseases |
Malnutrition Nutrition Disorders Hyperparathyroidism, Secondary Hyperparathyroidism Parathyroid Diseases Endocrine System Diseases Calcitriol Hormones Vitamins Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions Bone Density Conservation Agents Calcium Channel Agonists |
ClinicalTrials.gov processed this record on May 19, 2013