drugset / Trial / NCT01656512

Zometa Study in Pediatric Acute Lymphoblastic Leukemia

NCT01656512

Phase 3 Completed 95 enrolled Children's Cancer Hospital Egypt 57357
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

EvaluationDrugModalityDoseRoute
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

Indications