Analysis of Outcome of Bisphosphonate Use in Children With ALL- "Case Controlled Study"
5 Years
18 Years
Both
Osteoporosis
Trial Information
Analysis of Outcome of Bisphosphonate Use in Children With ALL- "Case Controlled Study"
Inclusion Criteria:
- Age above 5 & below 18 years at the time of diagnosis.
- Newly diagnosed ALL patients.
- Not previously treated, previous steroid intake not more than 72 hours.
- Treated according to St Judy study XV protocol.
Exclusion Criteria:
- Previous steroid intake more than 72 hours.
- Less than 5 years
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Outcome Measure:
Measure the change in the Bone densitometry due to secondary osteoporosis
Outcome Description:
we will do the following for evaluation : Bone densitometry using Dual-energy x-ray absorptiometry (DXA) scan analyzed using the Z-score. To be done : At baseline ( not more than 48 hours of start of therapy with steroids) At week 48 At end of treatment ( week 120 for girls ) & ( week 146 for boys) As required clinically eg: fractures . Magnetic resonance imaging of both hips & knees will be done at reinduction I & II & if symptomatic.
Outcome Time Frame:
1- At baseline ( not more than 48 hours of start of therapy with steroids) 2- At week 48 3- At end of treatment ( week 120 for girls ) & ( week 146 for boys) 4-As required clinically eg: fractures .
Safety Issue:
No
Principal Investigator
Shimaa Samir, MBBCH
Investigator Role:
Principal Investigator
Investigator Affiliation:
Children's Cancer Hospital Egypt 57357
Authority:
Egypt: Institutional Review Board
Study ID:
CCHE-ALL002
NCT ID:
NCT01656512
Start Date:
October 2011
Completion Date:
February 2013
Related Keywords:
- Osteoporosis
- ALL
- zoledronic acid
- Osteoporosis
- Leukemia, Lymphoid
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
- Osteoporosis
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