End Stage Renal Disease Clinical Trial
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.
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.
;
Allocation: Randomized, Primary Purpose: Treatment
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