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

  • STATUS
    Not Recruiting
  • End date
    Aug 19, 2023
  • participants needed
    150
  • sponsor
    Roswell Park Cancer Institute
Updated on 5 March 2022
x-rays
denosumab
osteoporosis
bone mineral density
RANKL
osteopenia
dual-energy x-ray absorptiometry
x-ray absorptiometry

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.

Description

PRIMARY OBJECTIVES:

I. To evaluate the efficacy and safety of denosumab therapy for the treatment of bone loss in patients who have received an allogeneic hematopoietic stem cell transplant.

OUTLINE

Patients receive 2 doses of denosumab subcutaneously (SC) between days 70-130 and days 250-310 after allogeneic hematopoietic stem cell transplant in the absence of disease progression or unacceptable toxicity.

After completion of study treatment patients are followed up at 6 months.

Details
Condition Metabolic Disorders, Osteoporosis, Allogeneic Hematopoietic Stem Cell Transplantation Recipient, bone loss, Metabolic disorder, decreased bone mineral density, Osteopenia, low bone density, Bone Diseases
Treatment Denosumab
Clinical Study IdentifierNCT03925532
SponsorRoswell Park Cancer Institute
Last Modified on5 March 2022

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