What this study is
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's being tested
- Zoledronate
Intervention · 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
- Official title
- Early Intervention With Zoledronate to Safely Prevent Bone Health Complications in Pediatric Hematopoietic Stem Cell Transplant Survivors
- Sponsor
- Children's Hospital Medical Center, Cincinnati
- Conditions
- Hematopoietic Stem Cell Transplantation
- Enrolling
- 20 people
- Starts
- 2026-07-17
- Est. completion
- 2028-11
- Design
- Open-label, single group, Phase 1
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 5 Years – 18 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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.
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openCincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
- Brady Landon · ContactBrady.Landon@cchmc.org
- Jonathan Howell, MD, PhD · Principal investigator
Recruiting
Study team
Sponsor
Children's Hospital Medical Center, Cincinnati
Study ID 2023-0052
Principal investigator
Jonathan Howell, MD, PhD
Children's Hospital Medical Center, Cincinnati
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.