Zometa Study in Pediatric Acute Lymphoblastic Leukemia

Children's Cancer Hospital Egypt 5735795 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Osteoporosis

Interventions

Eligibility

Sex: ALLMin age: 5 YearsMax age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age above 5 \& below 18 years at the time of diagnosis. * Newly diagnosed ALL patients. * Not previously treated, previous steroid intake not more than 72 hours. * Treated according to St Judy study XV protocol. Exclusion Criteria: * Previous steroid intake more than 72 hours. * Less than 5 years

Outcomes

Primary Outcomes

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 .

Secondary Outcomes

- To assess the percentage change in lumbar spine BMD at wk 48 relative to baseline in both arms.

Time frame: week 48 continuation phase