Prophylactic Risedronate for Patients With Peripheral Lung Tumors Treated With SBRT
| 适应症 | Lung Neoplasm |
|---|---|
| 分期 | 2期 |
| 申办方 | Wake Forest University Health Sciences |
| 状态 | 已完成 |
| 受试者人数 | 84 人 |
| 干预（药物） | risedronate, Matching placebo |
| 开始日期 | 2019年7月12日 |
| 完成日期 | 2022年3月2日 |
| 结果公布日 | 2023年7月14日 |
摘要
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
| Risedronate | 4.24 ± 3.04 percent change in mm cortical thickne |
|---|---|
| Matching Placebo | 7.14 ± 2.93 percent change in mm cortical thickne |
在 BENITIONS 中查看 查看 ClinicalTrials.gov 原文
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