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Prophylactic Risedronate for Patients With Peripheral Lung Tumors Treated With SBRT
Sponsor: Wake Forest University Health Sciences
Summary
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.
Official title: A Randomized Clinical Trial of Prophylactic Risedronate for Patients With Peripheral Lung Tumors Treated With SBRT
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
84
Start Date
2019-07-12
Completion Date
2022-03-02
Last Updated
2026-08-03
Healthy Volunteers
No
Conditions
Interventions
risedronate
Risedronate 150 mg Oral Given once 7 - 21 days prior to initiation of SBRT
Matching placebo
Dose not applicable, given once 7-21 days prior to initiation of SBRT
Locations (2)
High Point Regional Medical Center
High Point, North Carolina, United States
Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, United States