Prevention of Bone Loss After Pediatric Hematopoietic Cell Transplantation

NCT02074631 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 2013LS023
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

bone mineral content; bone mineral density; bone formation; bone resorption; pamidronate; children; DXA; bone marrow transplant

Outcome Measures

Primary Outcomes (1)

• Lumbar Spine Bone Mineral Content

  1 year after HCT

Secondary Outcomes (9)

• Total Body Bone Mineral Content (TBMC; Excluding Head; Adjusted for Height, Age, Sex, Tanner Stage, and Race)

  1 year after HCT

• Total Bone Mineral Density (BMD), Cortical BMD, Trabecular BMD, and Estimated Bone Strength Measured by pQCT

  1 year after HCT

• Cytokine Levels (Interleukin IL-6, IL-7, and TNF-α)

  7 days, 14 days, 21 days, 90 days after HCT

• Receptor Activator of the Nuclear Factor-κB Ligand [RANKL], Osteoprotegerin [OPG]

  7 days, 14 days, 21 days, and 90 days after HCT

• Marker of Bone Resorption (Carboxy-terminal Collagen Crosslinks [CTX]

  7, 14, 21, 90, 180, 360 days after HCT

Study Arms (2)

Control group

ACTIVE COMPARATOR

Subjects will receive a standard recommended dose of calcium and vitamin D.

Drug: Calcium and vitamin D

Pamidronate Group

EXPERIMENTAL

Subjects randomized to pamidronate treatment will receive infusions approximately 100, 180, and 270 days after HCT along with calcium and vitamin D.

Drug: Pamidronate; Drug: Calcium and vitamin D

Interventions

Pamidronate DRUG

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.

Also known as: Aredia, Bonapam

Pamidronate Group

Calcium and vitamin D DRUG

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.

Also known as: Cholecalciferol, Ergocalciferol

Control group; Pamidronate Group

Eligibility Criteria

• Age: 1 Year - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• History of a primary bone malignancy involving the lumbar spine
• Prior and/or planned concomitant medical therapy during the study period (through Day 360 post-HCT) with other bisphosphonates, Denosumab, or Teriparatide
• Pregnancy or breastfeeding - menstruating females must have a negative pregnancy test prior to study enrollment and agree to repeat pregnancy testing and contraception use per protocol as pamidronate is Pregnancy Category D - positive evidence of human fetal risk based on adverse reaction data
• Renal insufficiency, defined as creatinine level greater than the upper limit of normal for age
• Hereditary metabolic bone disease or skeletal dysplasia (e.g., osteopetrosis or OI) or primary hyperparathyroidism
• Other indications for HCT, including Fanconi anemia, other form of inherited bone marrow failure diseases, metabolic disorder, hemoglobinopathy, or immune deficiency
• Clinically significant fractures as defined by ISCD (a long bone fracture of the lower extremities, vertebral compression fracture, or two or more long bone fractures of the upper extremities) (88,89) indicated by a cast or a spine x-ray within the last 2 weeks
• Known or suspected allergy to pamidronate or related products
• Planned administration of an investigational study drug or agent that either can interact with pamidronate or have an independent effect on bone mineral density within the 4 weeks prior to randomization (Day 90) or planned use during study participation (Day 90 through Day 360)
• Impending invasive dental procedure that would be expected to occur during study participation (through Day 360)

Sponsors & Collaborators

• Masonic Cancer Center, University of Minnesota: lead

Study Sites (2)

University of Minnesota Amplatz Children's Hospital

Minneapolis, Minnesota, 55454, United States

Location

Seattle Children's Hospital

Seattle, Washington, 98105, United States

Location

Related Publications (55)

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  PMID: 17911175 RESULT

MeSH Terms

Conditions

Bone Diseases, Metabolic; Osteoporosis; Bone Resorption

Interventions

Pamidronate; Calcium; Vitamin D; Cholecalciferol; Ergocalciferols

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Metals, Alkaline Earth; Elements; Inorganic Chemicals; Metals; Blood Coagulation Factors; Biological Factors; Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Cholestenes; Cholestanes; Sterols; Membrane Lipids; Lipids

Results Point of Contact

• Title: Dr. Kyriakie Sarafoglou
• Organization: University of Minnesota, Masonic Cancer Center

saraf010@umn.edu

(612) 624-5965

Study Officials

• Kyriakie Sarafoglou, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2014
• First Posted: February 28, 2014
• Study Start: February 1, 2015
• Primary Completion: October 6, 2022
• Study Completion: October 6, 2022
• Last Updated: February 20, 2024
• Results First Posted: February 20, 2024

Record last verified: 2024-01

Locations

US (2)