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Osteoporosis in Children With ALL

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ClinicalTrials.gov Identifier: NCT00330538
Recruitment Status : Completed
First Posted : May 29, 2006
Last Update Posted : April 6, 2007
Sponsor:
Information provided by:
Children's Mercy Hospital Kansas City

Study Description
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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.


Condition or disease
Leukemia, Lymphocytic, Acute, L1

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 Design
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Study Type : Observational
Enrollment : 20 participants
Observational Model: Defined Population
Observational Model: Natural History
Time Perspective: Longitudinal
Time Perspective: Prospective
Official Title: Incidence of Osteoporosis in Children With Acute Lymphoblastic Leukemia Undergoing Therapy
Study Start Date : March 2004
Actual Study Completion Date : October 2006

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Groups and Cohorts
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   4 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00330538


Locations
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United States, Missouri
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
Sponsors and Collaborators
Children's Mercy Hospital Kansas City
Investigators
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Principal Investigator: Jadranka Popovic, MD Children's Mercy Hospital Kansas City
More Information
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ClinicalTrials.gov Identifier: NCT00330538    
Other Study ID Numbers: 03 08-085
First Posted: May 29, 2006    Key Record Dates
Last Update Posted: April 6, 2007
Last Verified: April 2007
Keywords provided by Children's Mercy Hospital Kansas City:
Osteoporosis
Childhood acute lymphoblastic leukemia
Additional relevant MeSH terms:
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Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Osteoporosis
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
 Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases