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Zoledronate to Prevent Bone Problems After Stem Cell Transplant in Children

This study is looking at whether giving a medication called zoledronate early can help prevent bone problems like low bone density and fractures in children who have had a hematopoietic stem cell transplant (HSCT). Zoledronate is a drug that helps strengthen bones. This study is for children aged 5 to 18 who are either preparing for an HSCT and already have low bone density, or who are recovering from an HSCT and have developed graft-versus-host disease (GVHD). The main goals are to see if zoledronate is safe when given early, and if it's practical to give it this way. The study plans to enroll 20 participants, but its current status is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It aims to enroll 20 children.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Safety will be checked from the time of infusion up to 60 days after the last dose of Zoledronate. Feasibility will be assessed at patient discharge, typically one week after infusion.

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NCT07375290

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

Recruiting
PHASE1Ages 5–18InterventionalPrevention
Children's Hospital Medical Center, Cincinnati
~20 participants
Updated 2026-08-10 on ClinicalTrials.gov
What's tested:Zoledronate

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety of early intervention Zoledronate
Measured over At the time of infusion through up to 60 days post last dose of Zoledronate
+1 more outcome measured

Conditions

Hematopoietic Stem Cell Transplantation

Explore related trials

Hematopoietic Cell Transplantation

Where it's being run

1 sites across 1 states
Ohio1

Study leadership

  • Jonathan Howell, MD, PhD · PRINCIPAL_INVESTIGATOR · Children's Hospital Medical Center, Cincinnati

Who to contact

Brady Landon
[email protected]
513-803-5490
Email the study team

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Safety of early intervention ZoledronateAt the time of infusion through up to 60 days post last dose of Zoledronate

    Calcium levels following infusion of zoledronate

  • Feasibility of early intervention ZoledronateAt patient discharge, typically 1 week post infusion

    Number of days required for inpatient stay beyond what is necessary for the patient's admission