Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03861091 · ClinicalTrials.gov registry record · Phase 2
Prophylactic Risedronate for Patients With Peripheral Lung Tumors Treated With SBRT
A Phase 2 study, sponsored by Wake Forest University Health Sciences.
- Completed
- Registry status
- Phase 2
- Development phase
- 84
- Enrollment target
NCT03861091 is a Phase 2 study that has completed, run by Wake Forest University Health Sciences. The registered enrollment target is 84 participants.
The verdict
NCT03861091, a Phase 2 study, has completed, sponsored by Wake Forest University Health Sciences.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 84 participants
- Enrollment target
Study Summary
This is a double blind randomized controlled study investigating the efficacy of a single dose of 150 mg risedronate (a bone anti-resorptive) vs a single dose of placebo given prior to SBRT for peripheral lung tumors that are within 2 cm of the chest wall. Our hypothesis is that the use of a single dose of 150 mg risedronate will eliminate or greatly reduce the rapid bone loss that occurs with radiation induced early osteoclast recruitment/activation. Patients will be given either a single dose of 150 mg risedronate or placebo at the time of their treatment mapping "simulation" CT scan. Typically, radiation treatments begin at 1 - 3 weeks following this mapping scan, as each treatment plan requires detailed physics calculations and quality assurance checks. All CT imaging referenced below is performed as a routine standard of care surveillance and is necessary for cancer treatment follow-up. These chest CT scans that are utilized in this research protocol would be performed every 3 months regardless of inclusion on this trial.
Interventions
- DRUG Matching placebo
- DRUG risedronate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 84 participants |
| Start Date | 2019-07-12 |
| Est. Completion | 2022-03-02 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03861091
The ClinicalTrials.gov registry entry for NCT03861091 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 84 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Wake Forest University Health Sciences, which has 1,140 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Matching placebo is the first listed.
NCT03861091 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03861091 about?
NCT03861091 is a clinical study titled "Prophylactic Risedronate for Patients With Peripheral Lung Tumors Treated With SBRT". This is a double blind randomized controlled study investigating the efficacy of a single dose of 150 mg risedronate (a bone anti-resorptive) vs a single dose of placebo given prior to SBRT for peripheral lung tumors that are within 2 cm of the chest wall. Our hypothesis is that the use of a single ...
What is the current status of trial NCT03861091?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 84 participants. The study started on 2019-07-12. Estimated completion is 2022-03-02.
What interventions are being tested in trial NCT03861091?
The interventions under investigation include: Matching placebo (DRUG), risedronate (DRUG).
Who is sponsoring clinical trial NCT03861091?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.