Zometa Study in Pediatric Acute Lymphoblastic Leukemia

Phase 3

Completed

• Conditions: Osteoporosis
• Interventions: Drug: calcium & vitamin D; Drug: zolendronic acid

• Registration Number: NCT01656512
• Lead Sponsor: Children's Cancer Hospital Egypt 57357

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2012-07-30
• Study First Submitted QC: 2012-08-01
• Study First Posted: 2012-08-03
• Primary Completion: 2014-01
• Study Completion: 2015-08
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-15
• Last Update Posted: 2018-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 95

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm ( A)	calcium & vitamin D	Arm ( A) : patients will receive calcium \& vitamin D
Arm (B)	zolendronic acid	we will give calcium and Vitamin D daily in addition to bisphosphonates (zolendronic acid ) every 3 months in the dose of

Primary Outcome Measures

Name	Time	Method
Measure the change in the Bone densitometry due to secondary osteoporosis	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 .	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.

Secondary Outcome Measures

Name	Time	Method
- To assess the percentage change in lumbar spine BMD at wk 48 relative to baseline in both arms.	week 48 continuation phase

Trial Locations

Locations (1)

Children's Cancer Hospital Egypt 57357; 🇪🇬 Cairo, Egypt