A Phase 3 interventional study of zolendronic acid and calcium & vitamin D in Osteoporosis, sponsored by Children's Cancer Hospital Egypt 57357. Completed at 1 site in Egypt. Open to participants aged 5 Years to 18 Years. Per ClinicalTrials.gov, last updated 2018-04-17.
Sponsored by Children's Cancer Hospital Egypt 57357 · Phase 3, Interventional, and Prevention
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.
1,640 studies on the registry are indexed under Osteoporosis; 212 are open to participants now.
This study's enrollment of 95 is close to the median of 95 across 1,133 interventional studies indexed under Osteoporosis.
Browse Osteoporosis studies →Children's Cancer Hospital Egypt 57357 is the lead sponsor of 18 studies on the registry; 2 are open to participants now.
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Arm ( A) : patients will receive calcium \& vitamin D
Drug: calcium & vitamin D
we will give calcium and Vitamin D daily in addition to bisphosphonates (zolendronic acid ) every 3 months in the dose of
Drug: zolendronic acid
patients will receive calcium \& vitamin D daily in addition to bisphosphonates (zolendronic acid ) every 3 months in the dose of 1. Initial dose: (0.025) mg /kg 2. Subsequent doses ( 0.05) mg /kg. 3. Maximum dose of 4 mg.
Also known as: bisphosphonates
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
Measure the change in the Bone densitometry due to secondary osteoporosis
we will do the following for evaluation : 1. 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 . 2. Magnetic resonance imaging of both hips \& knees will be done at reinduction I \& II \& if symptomatic.
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 .
- To assess the percentage change in lumbar spine BMD at wk 48 relative to baseline in both arms.
Time frame: week 48 continuation phase
This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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Children's Cancer Hospital Egypt 57357