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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm ( A) | Active Comparator | Arm ( A) : patients will receive calcium & vitamin D |
|
| Arm (B) | Experimental | we will give calcium and Vitamin D daily in addition to bisphosphonates (zolendronic acid ) every 3 months in the dose of |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| zolendronic acid | Drug | patients will receive calcium & vitamin D daily in addition to bisphosphonates (zolendronic acid ) every 3 months in the dose of
|
| Measure | Description | Time Frame |
|---|---|---|
| Measure the change in the Bone densitometry due to secondary osteoporosis | we will do the following for evaluation :
| 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 . |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shimaa Samir, MBBCH | Children's Cancer Hospital Egypt 57357 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Cancer Hospital Egypt 57357 | Cairo | 11441 | Egypt |
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| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D004164 | Diphosphonates |
| D002118 | Calcium |
| D014807 | Vitamin D |
| ID | Term |
|---|---|
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D008673 | Metals, Alkaline Earth |
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|
| calcium & vitamin D | Drug | 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 |
|
| D009750 |
| Nutritional and Metabolic Diseases |
| D004602 |
| Elements |
| D007287 | Inorganic Chemicals |
| D008670 | Metals |
| D001779 | Blood Coagulation Factors |
| D001685 | Biological Factors |
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |