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

National Center for Research Resources (NCRR)

Status and phase: Completed; Phase 2

Conditions: Renal Osteodystrophy; End Stage Renal Disease

Treatments: Drug: growth hormone; Drug: calcitriol

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00004340

199/11899

UCLA-612

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 1 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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