Recruiting
Phase 1

Zoledronate

Sponsor:

Children's Hospital Medical Center, Cincinnati

Code:

NCT07375290

Conditions

Hematopoietic Stem Cell Transplantation

Eligibility Criteria

Sex: All

Age: 5 - 18

Healthy Volunteers: Not accepted

Interventions

Zoledronate

Study Details

Brief summary:

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.

Conditions

Hematopoietic Stem Cell Transplantation

Study ID

NCT07375290

Start date

Jul 17, 2026

Status verified date

Aug, 2026

Completion date

Nov, 2028

Anticipated

Primary completion date

Jan, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 5 - 18

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

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.

Interventions

Zoledronate

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

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 ]
  • Feasibility of early intervention Zoledronate [ Time Frame: At patient discharge, typically 1 week post infusion ]

Central Contacts and Locations

Central contacts

Brady Landon

513-803-5490Brady.Landon@cchmc.org

Locations

Cincinnati Children's Hospital Medical Center

Recruiting

Cincinnati, Ohio, United States, 45229

Contacts

Brady Landon

Brady.Landon@cchmc.org

Principal Investigator:

Jonathan Howell, MD, PhD

More Information

Sponsor

Children's Hospital Medical Center, Cincinnati

Last update posted

Aug 10, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Children's Hospital Medical Center, Cincinnati on 2026-08-10.