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
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
- Renal Osteodystrophy
- End Stage Renal Disease
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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