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

RecruitingPhase 1

Early Intervention With Zoledronate to Safely Prevent Bone Health Complications in Pediatric Hematopoietic Stem Cell Transplant Survivors

Who can join

Ages 5 to 18 · All sexes

Full eligibility criteria
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.

About the study

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.

What is being tested

Sponsor: Children's Hospital Medical Center, Cincinnati · Participants: 20 · Started: Jul 17, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07375290

Locations in the U.S.

OhioCincinnati Children's Hospital Medical Center, Cincinnati

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.