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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

Tracking Information
First Submitted Date May 26, 2006
First Posted Date May 29, 2006
Last Update Posted Date April 6, 2007
Study Start Date March 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Osteoporosis in Children With ALL
Official Title Incidence of Osteoporosis in Children With Acute Lymphoblastic Leukemia Undergoing Therapy
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 Type Observational
Study Design Observational Model: Defined Population
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Not Provided
Study Population Not Provided
Condition Leukemia, Lymphocytic, Acute, L1
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Enrollment
 (submitted: May 26, 2006)
20
Original Enrollment Same as current
Actual Study Completion Date October 2006
Primary Completion Date Not Provided
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 4 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00330538
Other Study ID Numbers 03 08-085
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Not Provided
Study Sponsor Children's Mercy Hospital Kansas City
Collaborators Not Provided
Investigators
Principal Investigator: Jadranka Popovic, MD Children's Mercy Hospital Kansas City
PRS Account Children's Mercy Hospital Kansas City
Verification Date April 2007