Early zoledronate to prevent bone problems after pediatric stem cell transplant

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1 pilot will give zoledronate to high-risk pediatric HSCT patients either around the time of transplant or after they develop graft-versus-host disease, with the primary goal of characterizing safety and looking for preliminary signals of benefit. Eligible patients are 5–18 years old with a height-adjusted DXA Z-score < -2.0 prior to transplant or those who develop de novo acute or chronic GVHD after transplant; major exclusions include prior bisphosphonate use, low 25-OH vitamin D, renal dysfunction, active infection, and radiation-sensitive syndromes. Treatment is administered during an inpatient admission at Cincinnati Children's Hospital Medical Center and participants will be monitored for adverse events, renal function, mineral metabolism, and changes in bone mineral density. Outcomes include safety endpoints and early measures of bone density and fracture prevention over follow-up.

Why it matters

Who can join: the full rules

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.

Where it's running

• Cincinnati Children's Hospital Medical Center
  Cincinnati, Ohio, United States Recruiting

Study contacts

• Principal investigator: Jonathan Howell, MD, PhD — Children's Hospital Medical Center, Cincinnati
• Study coordinator: Brady Landon
• Email: Brady.Landon@cchmc.org
• Phone: 513-803-5490

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Population PK-guided ATG Dosing in Haploidentical Stem Cell Transplant

  This trial tests a population PK-guided ATG dosing strategy in people undergoing haploidentical hematopoietic stem cell transplantation to see if it improves outcomes.

  Recruiting Phase 3 Chinese PLA General Hospital · Beijing, Beijing Municipality · NCT07862127

• Population PK-guided ATG Dosing in Haplo-HSCT

  This study tests a population PK-guided dosing strategy for anti-thymocyte globulin (ATG) in adults and adolescents undergoing haploidentical stem cell transplantation to see if it can reduce GVHD while keeping relapse risk acceptable.

  Recruiting Phase 2 Chinese PLA General Hospital · Beijing, Beijing Municipality · NCT07791576

• Low-dose liposomal amphotericin B to prevent invasive fungal infections in neutropenic children

  This study tests whether giving a fixed low dose of liposomal amphotericin B can prevent invasive fungal infections in children aged 3–17 who are severely neutropenic after hematopoietic stem cell transplantation or similar high-risk conditions.

  Recruiting Haikou Affiliated Hospital of Central South University Xiangya School of Medicine · Haikou, Hainan · NCT07725263

• Personalized ATG dosing in unrelated donor stem cell transplants

  This trial tests whether tailoring anti-thymocyte globulin dosing works better than standard fixed dosing in adults and adolescents receiving unrelated donor stem cell transplants.

  Recruiting Phase 4 Chinese PLA General Hospital · Beijing, Beijing Municipality · NCT07648992

• Hematologic cancer survivors after stem cell transplant try a personalized care plan

  This study tests a personalized Survivorship Care Plan for people with hematologic cancer who have undergone a stem cell transplant to see if it’s feasible within the Italian health system.

  Recruiting Azienda USL Reggio Emilia - IRCCS · Reggio Emilia · NCT07579065

• T-cell–guided letermovir stopping after allogeneic stem cell transplant

  This tests whether using a CMV-specific T-cell blood test to decide when adult CMV-positive patients can stop letermovir after allogeneic stem cell transplant keeps them protected while avoiding unnecessary drug exposure.

  Recruiting Phase 4 Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Beijing, Beijing Municipality and 11 other locations · NCT07569653

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.