Viewing Study NCT00330538



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Study NCT ID: NCT00330538
Status: COMPLETED
Last Update Posted: 2007-04-06
First Post: 2006-05-26

Brief Title: Osteoporosis in Children With ALL
Sponsor: Childrens Mercy Hospital Kansas City
Organization: Childrens Mercy Hospital Kansas City

Study Overview

Official Title: Incidence of Osteoporosis in Children With Acute Lymphoblastic Leukemia Undergoing Therapy
Status: COMPLETED
Status Verified Date: 2007-04
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: Hypothesis

Pediatric patients with acute lymphoblastic leukemia treated with chronic glucocorticoids as a part of the leukemia treatment protocol will have an increased incidence and severity of osteoporosis
Detailed Description: Osteoporosis is a disease characterized by low bone mass and microarchitectural deterioration of bone tissue Osteoporosis is a devastating disorder with significant physical psychosocial and financial consequences Intensive chemotherapy and radiotherapy have led to significant improvements in long term disease-free survival of children with malignancies Unfortunately there are many deleterious side effects associated with this therapy Little is known about the longitudinal changes in bone mass accumulation and bone metabolism in these patients

The purpose of this study is to evaluate the timing and severity of changes in bone mineral metabolism for children treated for childhood leukemia Data will be used to establish treatment protocols with the goal of preventing severe fractures and pain in the acute treatment stage and severe osteoporosis and related pathology in the chronic stage

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None