drugset / Trial / NCT01656512
Zometa Study in Pediatric Acute Lymphoblastic Leukemia
RandomizedParallel-groupOpen-labelPrevention
Summary
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.
Timeline
- Start
- 2011-10
- Primary completion
- 2014-01
- Completion
- 2015-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Zoledronate | Other / unclassified | 0.05 mg/kg | — |
| Comparator | Calcitriol | Small molecule | 800 iu | — |
| Comparator | Calcitriol | Small molecule | 1000 iu | — |
| Comparator | Calcium carbonate | Other / unclassified | 1500 g | — |
| Comparator | Calcium carbonate | Other / unclassified | 2000 g | — |