About this trial
The purpose of this pilot study is to investigate the safety and preliminarily assess efficacy of early intervention with zoledronate in high risk pediatric hematopoietic stem cell transplantation (HSCT) patients to prevent the development of bone disease and fractures and reduce potential pain and suffering.
Eligibility criteria
Qualifiers
Patients ≥5 and ≤18 years old who are preparing for HSCT with a height-for-age corrected DXA Z-score of <-2.0 and admitted to a CCHMC inpatient unit.
Patients ≥5 and ≤18 years old recovering from HSCT and who have developed de novo acute or chronic GVHD and are admitted to a CCHMC inpatient unit.
Disqualifiers
Age <5 years and >18 years
Patients with Fanconi anemia or other radiation-sensitive syndromes with increased malignancy risk
history of prior bisphosphonate use
low 25-OH vitamin D levels (<20 ng/mL)
Trial design
Treatments tested in this trial
- Zoledronate