Zometa Study in Pediatric Acute Lymphoblastic Leukemia

Study Overview
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Brief Summary
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Acute Lymphoblastic Leukemia (ALL) is the most common malignancy in children. It accounts for one fourth of all childhood cancers & 74 % of childhood leukemia. Based upon drug registry data, children prescribed more than three courses of systemic glucocorticoids yearly faced a 20% increase in age-adjusted fracture rates. Rapid recovery occurred once glucocorticoids were discontinued, and fracture rates returned to expected for age by 1 year after treatment (Journal Of Clinical Endocrinology & Metabolism 2009). The investigators will study the role of bisphosphonates in the prevention of secondary osteoporosis in children & adolescents treated for ALL in the Children's Cancer Hospital -Egypt.

Official Title
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Analysis of Outcome of Bisphosphonate Use in Children With ALL- Case Controlled Study

Conditions
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Osteoporosis

Intervention / Treatment
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* Drug: zolendronic acid
* Drug: calcium & vitamin D


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm ( A)<br>Arm ( A) : patients will receive calcium & vitamin D | Drug: calcium & vitamin D<br>* patients will receive calcium & vitamin D Dose of Calcium : 1500- 2000 gram elemental Calcium daily . Dose of Vitamin D ( calcitriol; one alpha) 800-1000 International Unit<br>|
| Experimental: Arm (B)<br>we will give calcium and Vitamin D daily in addition to bisphosphonates (zolendronic acid ) every 3 months in the dose of | Drug: zolendronic acid<br>* patients will receive calcium & vitamin D daily in addition to bisphosphonates (zolendronic acid ) every 3 months in the dose of Initial dose: (0.025) mg /kg Subsequent doses ( 0.05) mg /kg. Maximum dose of 4 mg.<br>* Other names: bisphosphonates;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure the change in the Bone densitometry due to secondary osteoporosis | 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. | 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 . | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - To assess the percentage change in lumbar spine BMD at wk 48 relative to baseline in both arms. |  | week 48 continuation phase | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ALL, zoledronic acid, Osteoporosis