Clinical trial · Interventional
Zometa Study in Pediatric Acute Lymphoblastic Leukemia
Analysis of Outcome of Bisphosphonate Use in Children With ALL- "Case Controlled Study"
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Osteoporosis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| calcium & vitamin D | Drug | — | UNRESOLVED |
| zolendronic acid | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm ( A)
- description
- Arm ( A) : patients will receive calcium \& vitamin D
- interventionNames
- Drug: calcium & vitamin D
- type
- EXPERIMENTAL
- label
- Arm (B)
- description
- we will give calcium and Vitamin D daily in addition to bisphosphonates (zolendronic acid ) every 3 months in the dose of
- interventionNames
- Drug: zolendronic acid
Primary outcomes (1)
- measure
- Measure the change in the Bone densitometry due to secondary osteoporosis
- timeFrame
- 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 .
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 5 Years
- Maximum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available