CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 63 enrolled
Drug / intervention
Pamidronate +1 moredrug
Likely dose
Pamidronate 1 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02074631
NCT02074631Phase 2Completed
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Prevention of Bone Loss After Pediatric Hematopoietic Cell Transplantation

Masonic Cancer Center, University of Minnesota·interventional·Posted Feb 28, 2014·Updated Feb 20, 2024

In Brief

A Phase 2 clinical trial evaluating Pamidronate and Calcium and vitamin D for Osteopenia and Osteoporosis. Completed, enrolled 63 participants across 2 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteopenia, Osteoporosis
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedFeb 28, 2014
Enrollment StartFeb 1, 2015
Primary CompletionOct 6, 2022
TodayJul 2, 2026
Enrollment to primary: 7.7 yearsPosted 12.3 years ago

Interventions

Pamidronatedrug

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.

Calcium and vitamin Ddrug

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.