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

Part of paid clinical trials in Cincinnati, Ohio.

Sponsor
Children's Hospital Medical Center, Cincinnati
Study ID
NCT07375290
Phase
PHASE1
Status
Recruiting
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Conditions

  • Hematopoietic Stem Cell Transplantation

Eligibility Criteria

Sex
ALL
Age
5 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • Zoledronate — DRUG
    Zoledronate is in the class of drugs entitled bisphosphonates which act to inhibit bone resorption by inhibiting osteoclast activity therefore reducing bone turnover.

Study Details

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 Dates

Start date
Feb 28, 2026
Status verified
Jan 2026
Primary completion
Jan 31, 2028
Completion
Nov 30, 2028

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Experimental: Zoledronate
    Zoledronate dose will be given intravenously over 1 hour using standard infusion equipment. Patients will receive a dose of 0.025 mg/kg. Zoledronate will be infused in the inpatient setting to facilitate proper observation and data collection.

Primary Outcome Measure

Safety of early intervention Zoledronate [ Time Frame: At the time of infusion through up to 60 days post last dose of Zoledronate ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45229
Jessi Anderson
[email protected]
Jonathan Howell, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Cincinnati Children's Hospital Medical Center· Cincinnati, OH

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