Osteoporosis in Children With ALL

Leukemia, Lymphocytic, Acute, L1 Clinical Trial

Official title:

Incidence of Osteoporosis in Children With Acute Lymphoblastic Leukemia Undergoing Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00330538
• Other study ID #: 03 08-085
• Status: Completed
• Phase: N/A
• First received: May 26, 2006
• Last updated: April 5, 2007
• Start date: March 2004
• Est. completion date: October 2006

Study information

• Verified date: April 2007
• Source: Children's Mercy Hospital Kansas City
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 18 Years

Eligibility

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

Study Design

Observational Model: Defined Population, Time Perspective: Longitudinal

Related Conditions & MeSH terms

• Leukemia, Lymphocytic, Acute, L1
• Leukemia, Lymphoid
• Osteoporosis
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Locations

Country	Name	City	State
United States	Children's Mercy Hospital	Kansas City	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Children's Mercy Hospital Kansas City

Country where clinical trial is conducted

United States,