Actively Recruiting

Phase 1
Age: 5Years - 18Years
All Genders
NCT07375290

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

Led by Children's Hospital Medical Center, Cincinnati · Updated on 2026-01-29

20

Participants Needed

1

Research Sites

143 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 5Years - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 5 to 18 years preparing for HSCT with a height-for-age corrected DXA Z-score below -2.0 and admitted to a CCHMC inpatient unit
  • Patients aged 5 to 18 years recovering from HSCT who have developed new acute or chronic GVHD and are admitted to a CCHMC inpatient unit
Not Eligible

You will not qualify if you...

  • Age less than 5 years or greater than 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 (less than 20 ng/mL)
  • Active febrile illness
  • Uncontrolled infection
  • Elevated creatinine at enrollment, history of renal failure, or low glomerular filtration rate (GFR 90)
  • Active bone disease including abnormal PTH levels, active fractures or healing, or primary bone development or metabolism disorders
  • Women who are pregnant or breastfeeding

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States, 45229

Actively Recruiting

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Research Team

J

Jessi Anderson

CONTACT

B

Brady Landon

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

PREVENTION

Number of Arms

1

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