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| Sponsor: | National Center for Research Resources (NCRR) |
|---|---|
| Collaborators: |
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 |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized |
| 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--
--Prior/Concurrent Therapy--
--Patient Characteristics--
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
| Study ID Numbers: | 199/11899, UCLA-612 |
| Study First Received: | October 18, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00004340 History of Changes |
| Health Authority: | United States: Federal Government |
|
end stage renal disease rare disease renal and genitourinary disorders renal osteodystrophy |
|
Parathyroid Diseases Renal Insufficiency Molecular Mechanisms of Pharmacological Action Avitaminosis Calcium Channel Agonists Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Kidney Failure, Chronic Bone Density Conservation Agents Bone Diseases Hormones Calcitriol Membrane Transport Modulators Calcium Metabolism Disorders Hyperparathyroidism, Secondary |
Malnutrition Musculoskeletal Diseases Urologic Diseases Therapeutic Uses Vitamins Vasoconstrictor Agents Nutrition Disorders Micronutrients Kidney Diseases Deficiency Diseases Vitamin D Deficiency Metabolic Diseases Renal Osteodystrophy Growth Substances Endocrine System Diseases |
