Prophylactic Risedronate for Patients With Peripheral Lung Tumors Treated With SBRT

Completed · Phase 2 · Has a placebo group

Conditions studied: Lung Neoplasm

In brief

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.

Key facts

Study ID: NCT03861091
Run by: Wake Forest University Health Sciences
People needed: 84
Starts: 2019-07-12
Expected to finish: 2022-03-02
Last updated by the study team: 2026-08-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

Prior radiation to any part of the body including the lungs or thorax is not an exclusion criteria
Tumor edge is greater than 2 cm from the chest wall. The edge of tumor is the edge of the gross tumor volume or GTV as defined in radiation treatment planning software. This is determined by the treating radiation oncologist.
Tumors that are expected to require more than 10 fractions of radiation as determined by the treating radiation oncologist.
History of using bone anti-resorptive agents including bisphosphonates or RANK-L inhibitors within the last 1 year.
Inability to stand or sit upright for at least 30 minutes, which is necessary for ingestion of risedronate.
Hypocalcemia defined as serum total calcium lower than 8.5 mg/dL on most recent bloodwork that is within 3 months of administration of study drug/placebo.
Severe renal impairment (EGFR <30 mL/min) on most recent bloodwork that is within 3 months of administration of study drug/placebo.
Known allergy to risedronate or other bisphosphonates
Surgery affecting the bone or dental operations within the last 6 months. This will be explicitly asked and documented in the EMR by treating radiation oncologist.
Dental operations do not include routine cleaning or cavity fillings
Dental operations that exclude patients refer to any manipulation of mandible.
Positive urine pregnancy test in women of child bearing potential within 1 week of registration. Pregnant women are excluded from this study because radiation has clear teratogenic and potentially abortifacient risks.

Where it is running

High Point Regional Medical Center — High Point, North Carolina, United States
Wake Forest Baptist Comprehensive Cancer Center — Winston-Salem, North Carolina, United States

Full record on ClinicalTrials.gov

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