NCT01656512

Zometa Study in Pediatric Acute Lymphoblastic Leukemia

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 95 (actual)
• Sponsor: Children's Cancer Hospital Egypt 57357 · Academic / Other
• Sex: All
• Age: 5 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Osteoporosis

Interventions

Type	Name	Description
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.
DRUG	calcium & vitamin D	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

Timeline

• Start date: 2011-10-01
• Primary completion: 2014-01-01
• Completion: 2015-08-01
• First posted: 2012-08-03
• Last updated: 2018-04-17

Locations

1 site across 1 country: Egypt