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 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.
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This describes the study’s primary purpose.
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These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Aug 3, 2026 · Source: ClinicalTrials.gov
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Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- Wake Forest University Health Sciences
- Interventions being studied
- Drug: risedronate; Drug: Matching placebo
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- Patients must be 18 years or older, but there is no upper limit on age of inclusion.
- Patients must have a peripheral lung tumor that is amenable to SBRT as determined by the treating radiation oncologist. To be classified as a peripheral lung tumor, the tumor edge (the edge of the gross tumor volume or GTV in radiation treatment planning software) must be within 2 cm of the chest wall. This is determined by the treating radiation oncologist. The chest wall is defined as the chest wall musculature or ribs/vertebrae immediately adjacent to the lungs.
- Patients must have ECOG status of 0-3
- Patients must have a life expectancy of at least 3 months as determined by the treating radiation oncologist.
- Patients must have the ability to understand and the willingness to sign an IRB-approved informed consent document.
Prior radiation to any part of the body including the lungs or thorax is not an
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- High Point Regional Medical CenterHigh Point, North Carolina
- Wake Forest Baptist Comprehensive Cancer CenterWinston-Salem, North Carolina
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 3, 2026. Always confirm current availability with the study team.