This phase II trial studies how well prophylactic risedronate works in reducing rapid bone loss in patients with peripheral lung tumors who are undergoing stereotactic body radiation therapy (SBRT). Risedronate is a type of drug called a bisphosphonate. This type of medicine is commonly used to decrease bone loss in people who have osteoporosis, but it has not been given to stop bone loss that is caused by radiation. Giving risedronate prior to SBRT may stop or decrease bone loss that is caused by radiation. This could potentially lead to fewer rib or backbone fractures and could mean patients experience less chest or back pain after radiation.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03861091.
PRIMARY OBJECTIVE:
I. To assess the percent change in bone mean cortical thickness within regions of bone receiving 30 Gy or more at 3 months after SBRT.
SECONDARY OBJECTIVES:
I. Further analyze the remaining routine follow-up chest computed tomography (CT) scans, for mean cortical thickness change in regions of bone that received 0 – 10 Gy, > 10 – 20 Gy, > 20 – 30 Gy, > 30 – 40 Gy, and > 40 Gy at all time points including 3 months, 6 months, 9 months, and 12 months.
II. Assess and compare the incidence and grade (per modified Common Terminology Criteria for Adverse Events [CTCAE] version [v].5) of radiation induced chest wall pain within the radiation treatment portal (within the 50% isodose line) at time of each routine follow up visit (3 months, 6 months, 9 months, and 12 months post SBRT).
III. Assess and compare the incidence of rib and vertebral fractures (as noted on CT imaging) that occur within 12 months of irradiation and are within the radiation treatment field.
IV. The urine concentration of an osteoclast-specific biomarker, urinary N-telopeptide (NTX) indicating osteoclast activity will be assessed prior to SBRT and at each routine follow up visit (at 3 months, 6 months, 9 months, and 12 months post SBRT).
EXPLORATORY OBJECTIVE:
I. Assess the relation between calculated dose and development of/grade of chest wall pain during follow-up.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Within 7-21 days prior to initiation of standard SBRT, patients receive risedronate sodium orally (PO) once.
ARM II: Within 7-21 days prior to initiation of standard SBRT, patients receive placebo PO once.
After completion of study treatment, patients are followed up at 1, 3, 6, 9, and 12 months.
Lead OrganizationWake Forest University Health Sciences
Principal InvestigatorMichael K. Farris
