Osteoporosis in Children With ALL - Full Text View

Sponsored by:	Children's Mercy Hospital Kansas City
Information provided by:	Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier:	NCT00330538

Purpose

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.

Condition
Leukemia, Lymphocytic, Acute, L1

Study Type:	Observational
Study Design:	Natural History, Longitudinal, Defined Population, Prospective Study
Official Title:	Incidence of Osteoporosis in Children With Acute Lymphoblastic Leukemia Undergoing Therapy

Resource links provided by NLM:

MedlinePlus related topics: Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood Osteoporosis

U.S. FDA Resources

Further study details as provided by Children's Mercy Hospital Kansas City:

Estimated Enrollment:	20
Study Start Date:	March 2004
Study Completion Date:	October 2006

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.

Eligibility

Ages Eligible for Study:	4 Years to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

All pediatric patients with a new diagnosis of ALL between ages 4-18
Patients who are expected to receive glucocorticoids as part of the leukemia treatment protocol
Bone density measurements must be performed at the diagnosis visit or maximally within 48 hours after the first dose of glucocorticoids

Exclusion Criteria:

Patients under 4 years of age are excluded due to lack of age appropriate standards for bone mineral density
Glucocorticoid therapy of at least one month or longer within the six months prior to DX
History of connective tissue or musculoskeletal disorders
Biphosphonate therapy within the past 6 months
Acute renal failure
Serum creatinine equal to or higher than 4.5mg/dl
Positive serum pregnancy test in adolescent females

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00330538

Locations

United States, Missouri
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108

Sponsors and Collaborators

Children's Mercy Hospital Kansas City

Investigators

Principal Investigator:

Jadranka Popovic, MD

Children's Mercy Hospital

More Information

No publications provided

Study ID Numbers:	03 08-085
Study First Received:	May 26, 2006
Last Updated:	April 5, 2007
ClinicalTrials.gov Identifier:	NCT00330538 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Children's Mercy Hospital Kansas City:

Osteoporosis
Childhood acute lymphoblastic leukemia

Study placed in the following topic categories:

Acute Lymphoblastic Leukemia, Childhood
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immunoproliferative Disorders
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases

Leukemia
Lymphatic Diseases
Musculoskeletal Diseases
Lymphoproliferative Disorders
Lymphoma
Acute Lymphoblastic Leukemia

Additional relevant MeSH terms:

Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Immunoproliferative Disorders
Immune System Diseases
Osteoporosis
Bone Diseases, Metabolic

Bone Diseases
Leukemia
Lymphatic Diseases
Neoplasms
Musculoskeletal Diseases
Lymphoproliferative Disorders

ClinicalTrials.gov processed this record on September 01, 2009