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One pill before radiation: a new shield for bones?

NCT ID NCT03861091

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

Jul 2019

Finished

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

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

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

  • Wake Forest Baptist Comprehensive Cancer Center

    Winston-Salem, North Carolina, 27157, United States

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