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NCT03925532 · ClinicalTrials.gov registry record · Phase 2
Denosumab in Treating Patients With Bone Loss Due to Donor Stem Cell Transplant
A Phase 2 study, sponsored by Roswell Park Cancer Institute.
- Completed
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
NCT03925532: Completed Phase 2 study, sponsored by Roswell Park Cancer Institute.
NCT03925532 is a Phase 2 study that has completed, run by Roswell Park Cancer Institute. The registered enrollment target is 30 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03925532, a Phase 2 study, has completed, sponsored by Roswell Park Cancer Institute.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
Study 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.
Primary Outcome
Day 0 dual x-ray absorptiometry (DXA) scan and day 465 DXA scan will be compared based on the percent change in BMD in the Total hip in allogeneic HSCT patients who have experienced either at least 5% BMD loss between baseline (pre- HSCT) and day + 100 post-HSCT, or who have osteopenia or osteoporosis at either the pre-bone marrow transplant or day + 100 DXA scan.
Interventions
- BIOLOGICAL Denosumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2019-12-19 |
| Est. Completion | 2022-11-16 |
| Phase | Phase 2 |
What the finished NCT03925532 record still lists
NCT03925532 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 1 intervention - of which Denosumab is the first listed.
NCT03925532 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03925532 about?
NCT03925532 is a clinical study titled "Denosumab in Treating Patients With Bone Loss Due to Donor Stem Cell Transplant". 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, lead...
What is the current status of trial NCT03925532?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2019-12-19. Estimated completion is 2022-11-16.
What interventions are being tested in trial NCT03925532?
The interventions under investigation include: Denosumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT03925532?
This trial is sponsored by Roswell Park Cancer Institute, which has 365 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03925532's enrollment target sits among peer trials
30 1582nd of 2000 higher than 332 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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