CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 30 enrolled
Drug / intervention
Denosumabbiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03925532
NCT03925532Phase 2Completed

A Phase II Multicenter, Single Arm, Open-Label Trial to Evaluate the Efficacy and Safety of Denosumab in Treatment of Post-Allogenic Hematopoietic Stem Cell Transplant Bone Loss

Roswell Park Cancer Institute·interventional·Posted Apr 24, 2019·Updated Mar 13, 2024

In Brief

A Phase 2 clinical trial evaluating Denosumab for Allogeneic Hematopoietic Stem Cell Transplantation Recipient and 2 related conditions. Completed, enrolled 30 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsAmgen

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedApr 24, 2019
Enrollment StartDec 19, 2019
Primary CompletionNov 16, 2022
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 7.2 years ago

Interventions

Denosumabbiological

Given SC