One pill before radiation: a new shield for bones?
NCT ID NCT03861091
First seen Aug 03, 2026 · Last updated Aug 04, 2026 · Updated 1 time
Summary
This trial tests whether a single dose of risedronate, a bone-strengthening drug, given before stereotactic body radiation therapy (SBRT) for peripheral lung tumors can prevent the rapid bone loss that radiation can cause in nearby ribs. Adults with lung tumors within 2 cm of the chest wall will receive either risedronate or a placebo before their radiation planning scan. The study measures changes in bone thickness over a year to see if the drug protects bone health.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- risedronate (a bone-strengthening drug)
- What this could lead to
- If it works, a single dose of risedronate before radiation therapy could protect nearby bones from weakening, reducing fracture risk and improving quality of life for lung cancer patients.
- What could go wrong
- This is a small, early-stage trial, and the benefit may not be significant. Risedronate can cause side effects like stomach upset or jaw problems, though rare.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
84 people
The number who actually took part.
- Started
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Jul 2019
- Finished
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Mar 2022
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion 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. Exclusion Criteria: 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
High Point Regional Medical Center
High Point, North Carolina, 27262, United States
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Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157, United States
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Other studies related to the condition(s) this trial covers.
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