Prevention of Bone Loss After Pediatric Hematopoietic Cell Transplantation (NCT02074631) | Clinical Trial Compass
CompletedPhase 2
Prevention of Bone Loss After Pediatric Hematopoietic Cell Transplantation
United States63 participantsStarted 2015-02
Plain-language 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).
Who can participate
Age range1 Year – 20 Years
SexALL
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Inclusion Criteria:
* Allogeneic hematopoietic cell transplant for hematologic malignancy (i.e. leukemia, lymphoma including ALL, AML, CML, NHL, HL) in complete remission; myelodysplastic syndrome (active dysplasia and/or blasts are permitted, but must not have active leukemia) or idiopathic severe aplastic anemia (SAA)
* Non-malignant diseases including idiopathic severe aplastic anemia (SAA) and other bone marrow failure disorders, hemoglobinopathies, adrenoleukodystrophy, immune deficiencies/dysregulation disorders who will be receiving myeloablative or reduced toxicity preparative regimens that meet the following criteria:
* Regimens include those that are TBI based if the TBI dose is \> 500cGy single dose or \> 800cGy fractionated, or doses \<500 cGy if combined with busulfan or treosulfan. These also include chemotherapy only based regimens that contain myeloablative doses of busulfan (\>8mg/kg) or treosulfan without TBI.
* Patients with severe aplastic anemia are eligible regardless of conditioning regimen
* Myeloablative preparative regimen (for SAA any conditioning therapy allowed)
* Male or female ≥1 but ≤ 20 years of age at time of study enrollment
* Patient or parent(s)/legal guardian(s) is able and willing to provide informed consent. Assent will be obtained per local institutional policy. Subjects who turn 18 during the course of the study will be consented at that time of their next visit by a member of the research staff.
Exclusion Criteria:
* History …
What they're measuring
1
Lumbar Spine Bone Mineral Content
Timeframe: 1 year after HCT
Trial details
NCT IDNCT02074631
SponsorMasonic Cancer Center, University of Minnesota