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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Center for Research Resources (NCRR)
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); University of California, Los Angeles
• Treatments: Calcitriol; Hormones

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