BENITIONSClinical Trial Intelligence

Prophylactic Risedronate for Patients With Peripheral Lung Tumors Treated With SBRT

Фаза 2 Завершено NCT03861091

ЗаболеваниеLung Neoplasm
ФазаФаза 2
СпонсорWake Forest University Health Sciences
СтатусЗавершено
Участники84 участн.
Вмешательствоrisedronate, Matching placebo
Дата начала12.07.2019
Дата завершения2.03.2022
Публикация результатов14.07.2023

Кратко

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.

Changes in Mean Cortical Thickness

At baseline and at 3 months post radiation · percent change in mm cortical thickne

Risedronate4.24 ± 3.04 percent change in mm cortical thickne
Matching Placebo7.14 ± 2.93 percent change in mm cortical thickne

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