Trials / Completed
CompletedNCT00004340
Phase II Randomized Study of the Effects of Growth Hormone on Children and Adolescents on Maintenance Dialysis
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 109 (planned)
- Sponsor
- National Center for Research Resources (NCRR) · NIH
- Sex
- All
- Age
- 1 Year – 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | calcitriol | |
| DRUG | growth hormone |
Timeline
- Start date
- 1995-06-01
- First posted
- 1999-10-19
- Last updated
- 2005-06-24
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00004340. Inclusion in this directory is not an endorsement.