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Denosumab in Treating Patients With Bone Loss Due to Donor Stem Cell Transplant

NCT03925532 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-03-13

Study results available
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Summary

This Phase II trial studies the side effects of denosumab and to see how well it works in treating patients with bone loss who have received a donor stem cell transplant. Patients receiving a donor stem cell transplant may experience accelerated bone loss and an increase risk of bone fractures, leading to a decrease in satisfaction and quality of life. A type of immunotherapy drug called denosumab binds to a protein called RANKL, which may help keep bone from breaking down.

Conditions

  • Allogeneic Hematopoietic Stem Cell Transplantation Recipient
  • Osteopenia
  • Osteoporosis

Interventions

BIOLOGICAL

Denosumab

Given SC

Sponsors & Collaborators

  • Amgen

    collaborator INDUSTRY

  • Roswell Park Cancer Institute

    lead OTHER

Principal Investigators

  • Philip L McCarthy · Roswell Park Cancer Institute

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-19
Primary Completion
2022-11-16
Completion
2022-11-16
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03925532 on ClinicalTrials.gov