Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004340
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-10-18
Brief Title:
Phase II Randomized Study of the Effects of Growth Hormone on Children and Adolescents on Maintenance Dialysis
Sponsor:
National Center for Research Resources NCRR
Organization:
National Center for Research Resources NCRR
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2002-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UCLA-612 | None | None | None |