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

Recruiting now · Phase 1

Conditions studied: Hematopoietic Stem Cell Transplantation

In brief

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.

Key facts

Study ID: NCT07375290
Run by: Children's Hospital Medical Center, Cincinnati
People needed: 20
Starts: 2026-07-17
Expected to finish: 2028-11-01
Last updated by the study team: 2026-08-10

Who can join

Age: 5 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States (enrolling)

Full record on ClinicalTrials.gov

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