Osteonecrosis in Children With Acute Lymphoblastic Leukemia

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Brief Title

Osteonecrosis in Children With Acute Lymphoblastic Leukemia

Official Title

Steroid Induced Osteoporosis in the Pediatric Population Ancillary Study- Osteonecrosis in Children With Acute Lymphoblastic Leukemia

Brief Summary

      Acute lymphoblastic leukemia is the most common form of childhood cancer with current
      treatment survival rates approaching 80%. Improved outcomes show an increased number of
      survivors at risk for long-term treatment related side effects including osteonecrosis.
      Osteonecrosis, or bone death, is caused by blood supply loss to the bone causing pain and
      poor quality of life. The hips, shoulders, knees and ankles may be affected. Pain is the
      usual presenting symptom and may become severe requiring surgical decompression or
      replacement of the affected joint. Long-term effects including arthritis and progressive
      joint difficulties will not be known for decades. This study aims to determine the risk
      factors for developing osteonecrosis that will lead to information for earlier detection and
      prevention. The study will be the basis for future intervention and prevention trials.
    



Study Type

Observational


Primary Outcome

osteonecrosis 1 year post leukemia therapy

Secondary Outcome

 Bone mass density and Osteonecrosis

Condition

Osteonecrosis



Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

130

Start Date

July 2009

Completion Date

December 2012

Primary Completion Date

December 2012

Eligibility Criteria

        Inclusion Criteria:

          -  Enrollment in the STOPP-CIS study

          -  Informed consent of patient or care givers

          -  >5 years of age at MRI assessment

        Exclusion Criteria:

          -  Individuals with a history of claustrophobia precluding MRI assessment
      

Gender

All

Ages

5 Years - 18 Years

Accepts Healthy Volunteers

No

Contacts

Jacqueline Halton, 613 737 7600, 

Location Countries

Canada

Location Countries

Canada

Administrative Informations


NCT ID

NCT01104324

Organization ID

08/20E



Study Sponsor

Halton, Jacqueline, M.D.

Collaborators

 C17 Council

Study Sponsor

Jacqueline Halton, Principal Investigator, Childrens Hospital of Easten Ontario


Verification Date

April 2010