Early Intervention With Zoledronate to Safely Prevent Bone Health Complications in Pediatric Hematopoietic Stem Cell Transplant Survivors
Children's Hospital Medical Center, Cincinnati
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.
Description
Bone disease, including low bone density and fragility fractures (osteoporosis), is common among survivors of pediatric hematopoietic stem cell transplantation (HSCT). Further, patients who develop graft-versus-host disease (GVHD) following HSCT or who have high cumulative doses of glucocorticoids are at even higher risk to develop bone complications. Recent data also suggest that a large number of HSCT candidates arrive to transplantation already with low bone mineral density, adding to the potential risk of developing bone disease following HSCT. Typically, treatment for osteoporosis in chil…
Eligibility
- Age range
- 5–18 years
- Sex
- All
- Healthy volunteers
- No
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 in…
Interventions
- DrugZoledronate
Zoledronate is in the class of drugs entitled bisphosphonates which act to inhibit bone resorption by inhibiting osteoclast activity therefore reducing bone turnover.
Location
- Cincinnati Children's Hospital Medical CenterCincinnati, Ohio