Zometa Study in Pediatric Acute Lymphoblastic Leukemia

NCT01656512 — Phase 3, Completed, 95 participants, Children's Cancer Hospital Egypt 57357

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

Registry	NCT01656512
Status	Completed
Phase	Phase 3
Study type	Interventional; randomized, parallel, masking: none, prevention
Enrollment	95 (Actual)
Sponsor	Children's Cancer Hospital Egypt 57357 (Other)
Conditions	Osteoporosis
Interventions	zolendronic acid, calcium & vitamin D (Drug)
Dates	start 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 in Egypt

-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.

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+Arms and interventions

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

zolendronic acid (Drug), also known as bisphosphonates: 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.
calcium & vitamin D (Drug): 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

+Outcome measures

Primary outcomes

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 outcomes

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

+Eligibility

Sex: All, ages: 5 Years to 18 Years

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

+Locations (1)

Facility	City	Country	Status
Children's Cancer Hospital Egypt 57357	Cairo	Egypt

+Investigators

Shimaa Samir, MBBCH, Principal investigator, Children's Cancer Hospital Egypt 57357