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.
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.
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.
| 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 Identifier | NCT03925532 |
| Sponsor | Roswell Park Cancer Institute |
| Last Modified on | 5 March 2022 |
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