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Zoledronate to Prevent Bone Health Complications in Pediatric Hematopoietic Stem Cell Transplant Survivors

RecruitingPhase 1Ages 5 Years - 18 YearsAllChildren's Hospital Medical Center, Cincinnati
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * 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. Exclusion Criteria: * 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) * active febrile illness * uncontrolled infection * Elevated creatinine at the time of enrollment, history or renal failure, or documented low glomerular filtration rate (GFR≤90) * Active bone disease including history of abnormal PTH level for any reason, active bone fracture/healing, or primary disorder of bone development or metabolism. * Women who are pregnant or breast feeding.
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What it tests

  • Zoledronate
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Where

1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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