CompletedPhase 2NCT03861091
Official study title

Prophylactic Risedronate for Patients With Peripheral Lung Tumors Treated With SBRT

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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedrisedronate and Matching placebo

The study team can explain what participation involves.

Who it may be forLung Neoplasm

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Aug 3, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?2 U.S. locations

Locations may change over time.

Who runs it?Wake Forest University Health Sciences

Study sponsor

01
Study overview

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
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Treatment approach
03
Public criteria

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.

Requirements people may need to meetInclusion criteria
  • 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.
Reasons someone may not be able to joinExclusion criteria

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.

04
Study sites

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.

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