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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age5-18
SponsorChildren's Hospital Medical Center, Cincinnati

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

Treatment groups

20 Participants
are divided into 1 treatment group