Prevention of Bone Loss After Pediatric Hematopoietic Cell Transplantation
Complete title: Prevention of Bone Loss after Pediatric Hematopoietic Cell Transplantation
This is a Phase 2, open-label, randomized, controlled clinical study of pediatric subjects treated with pamidronate with calcium and vitamin D versus calcium and vitamin D alone following hematopoetic cell transplantation (HCT). The purpose of this study is to test the hypothesis that subjects receiving pamidronate with calcium and vitamin D will have higher lumbar spine bone mineral content (LBMC) measured by dual-energy X-ray tomography (DXA) at 1 year post-HCT than subjects receiving calcium and vitamin D alone (Control Group). Sixty subjects (=1 and <18 years of age at the time of enrollment and receiving an allogeneic HCT for a hematologic malignancy or severe aplastic anemia) will be evaluated at the University of Minnesota Amplatz Children's Hospital and Seattle Children's Hospital. Subjects randomized to pamidronate treatment will receive infusions approximately 100, 180, and 270 days after HCT. Laboratory evaluations, DXA, and peripheral quantitative computed tomography (pQCT) will be performed at specified time points to evaluate safety and treatment efficacy. Subjects will participate in the study for 1 year.
** For Eligibility information, please click on the "Look up trial at NIH" link above. **
Other eligibility criteria may apply.
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Hematologic Malignancies; Hematopoietic Cell Transplantation (HCT); Osteoporosis; Osteopenia
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