Zometa Study in Pediatric Acute Lymphoblastic Leukemia

Osteoporosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01656512
• Other study ID #: CCHE-ALL002
• Status: Completed
• Phase: Phase 3
• First received: July 30, 2012
• Last updated: April 15, 2018
• Start date: October 2011
• Est. completion date: August 2015

Study information

• Verified date: April 2018
• Source: Children's Cancer Hospital Egypt 57357
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: August 2015
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Drug:
• zolendronic acid
patients will receive calcium & vitamin D daily in addition to bisphosphonates (zolendronic acid ) every 3 months in the dose of Initial dose: (0.025) mg /kg Subsequent doses ( 0.05) mg /kg. Maximum dose of 4 mg.
• 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

Locations

Country	Name	City	State
Egypt	Children's Cancer Hospital Egypt 57357	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Children's Cancer Hospital Egypt 57357

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure the change in the Bone densitometry due to secondary osteoporosis	we will do the following for evaluation : 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 .; Magnetic resonance imaging of both hips & knees will be done at reinduction I & II & if symptomatic.	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	- To assess the percentage change in lumbar spine BMD at wk 48 relative to baseline in both arms.		week 48 continuation phase