End Stage Renal Disease, Renal Osteodystrophy
Conditions
Keywords
end stage renal disease, rare disease, renal and genitourinary disorders, renal osteodystrophy
Brief 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.
Detailed 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.
Interventions
DRUGcalcitriol
DRUGgrowth hormone
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of California, Los Angeles
National Center for Research Resources (NCRR)
Study design
Allocation
RANDOMIZED
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
1 Years to 18 Years
Healthy volunteers
No
Inclusion 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
Countries
United States
Outcome results
None listed