Osteoporosis in Children With ALL

This study has been completed.
Sponsor:
Information provided by:
Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier:
NCT00330538
First received: May 26, 2006
Last updated: April 5, 2007
Last verified: April 2007

May 26, 2006
April 5, 2007
March 2004
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Complete list of historical versions of study NCT00330538 on ClinicalTrials.gov Archive Site
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Osteoporosis in Children With ALL
Incidence of Osteoporosis in Children With Acute Lymphoblastic Leukemia Undergoing Therapy

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.

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.

Observational
Observational Model: Defined Population
Time Perspective: Longitudinal
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Leukemia, Lymphocytic, Acute, L1
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
October 2006
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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
Both
4 Years to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00330538
03 08-085
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Children's Mercy Hospital Kansas City
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Principal Investigator: Jadranka Popovic, MD Children's Mercy Hospital
Children's Mercy Hospital Kansas City
April 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP