NCT02074631

Prevention of Bone Loss After Pediatric Hematopoietic Cell Transplantation

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: Masonic Cancer Center, University of Minnesota · Academic / Other
• Sex: All
• Age: 1 Year – 20 Years
• Healthy volunteers: Not accepted

Summary

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 hematopoietic 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).

Conditions

• Osteopenia
• Osteoporosis

Interventions

Type	Name	Description
DRUG	Pamidronate	Subjects randomized to pamidronate treatment will receive infusions, 1 mg/kg (to a max dose of 60mg) over 4 hours, every 3 months at approximately 100 days, 180 days, and 270 days after HCT.
DRUG	Calcium and vitamin D	All subjects will receive a standard recommended dose of 600 IU/day of vitamin D. Subjects who do not meet the RDA will receive additional calcium supplementation.

Timeline

• Start date: 2015-02-01
• Primary completion: 2022-10-06
• Completion: 2022-10-06
• First posted: 2014-02-28
• Last updated: 2024-02-20
• Results posted: 2024-02-20

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study