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Peer-reviewedCC BY-NC-ND 4.0JTO Clinical and Research Reports

Effect of Risedronate on Rib Cortical Thickness After Stereotactic Body Radiotherapy to Peripheral Lung Tumors: Results of a Randomized Phase 2 Trial

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7 affiliations
  1. 1Department of Radiation Oncology, Wake Forest University School of Medicine, Winston Salem, North Carolina; Corresponding author. Address for correspondence: Ryan T. Hughes, MD, Department of Radiation Oncology, Wake Forest University School of Medicine, Medical Center Blvd, Winston Salem, North Carolina.
  2. 2Department of Radiation Oncology, Wake Forest University School of Medicine, Winston Salem, North Carolina
  3. 3Department of Biostatistics and Data Science, Wake Forest University School of Medicine, Winston Salem, North Carolina
  4. 4Department of Social Sciences and Health Policy, Wake Forest University School of Medicine, Winston Salem, North Carolina
  5. 5Department of Radiology, Wake Forest University School of Medicine, Winston Salem, North Carolina
  6. 6Department of Cancer Medicine, Wake Forest University School of Medicine, Winston Salem, North Carolina
  7. 7Department of Anesthesiology, Wake Forest University School of Medicine, Winston Salem, North Carolina

Abstract

Introduction: Stereotactic body radiotherapy (SBRT) to peripheral lung tumors is associated with radiation-induced bone effects that may predispose patients to chest wall pain and radiation-induced rib fractures. These effects may be inhibited by bisphosphonates. We aimed to determine the impact of risedronate on the radiologic biomarker of rib cortical thickness (CTh) in patients with peripheral lung tumors treated with SBRT. Methods: This randomized, double-blind, placebo-controlled phase 2 clinical trial enrolled patients with tumors within 2 cm of the chest wall, who were randomized 1:1 to receive risedronate 150 mg prior to SBRT or placebo. CTh was evaluated every 3 months for 1 year. The primary endpoint was the percent change in rib CTh from baseline to 3 months within the higher than 30 Gy isodose region. Results: Seventy-three patients (78 tumors) were randomized and eligible for analysis. Baseline CTh was 1.46 (± 0.34) mm and 1.44 (± 0.42) mm in the placebo and risedronate arms, respectively. The mean percent change from baseline to 3 months within the 30 Gy isodose region was 6.4% (± 18.0) for placebo versus 3.1% (± 17.9) for risedronate (absolute difference: −3.3%; p = 0.44). The absolute differences in percent CTh change from baseline to 6, 9, and 12 months in the risedronate (versus placebo) group were −4.7%, −8.3%, and −11.8%, respectively. Conclusion: In patients with peripheral lung tumors treated with SBRT, risedronate did not result in statistically significant differences in CTh within the 30 Gy isodose region. This biomarker of bone changes after SBRT demonstrated increases over time within higher dose regions in the placebo group but remained similar to baseline in the risedronate group. Further studies are needed.

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BibTeX
@article{ryanthughes2026effect,
  title = {{Effect of Risedronate on Rib Cortical Thickness After Stereotactic Body Radiotherapy to Peripheral Lung Tumors: Results of a Randomized Phase 2 Trial}},
  author = {Ryan T. Hughes, MD and Paul J. Black, PhD and India R. Wood, MS and Anna C. Snavely, PhD and Beverly J. Levine, PhD and Justin M. Napolitano, PhD and Heather D. Pacholke, MD and Janardhana Ponnatapura, MD and Kathryn E. Weaver, PhD and Glenn J. Lesser, MD and Sun H. Park, PhD and Jeffrey S. Willey, PhD and Michael K. Farris, MD},
  journal = {JTO Clinical and Research Reports},
  year = {2026},
  month = aug,
  doi = {10.1016/j.jtocrr.2026.101069},
  url = {https://doi.org/10.1016/j.jtocrr.2026.101069},
  note = {CC BY-NC-ND 4.0},
}
RIS
TY  - JOUR
TI  - Effect of Risedronate on Rib Cortical Thickness After Stereotactic Body Radiotherapy to Peripheral Lung Tumors: Results of a Randomized Phase 2 Trial
AU  - Ryan T. Hughes, MD
AU  - Paul J. Black, PhD
AU  - India R. Wood, MS
AU  - Anna C. Snavely, PhD
AU  - Beverly J. Levine, PhD
AU  - Justin M. Napolitano, PhD
AU  - Heather D. Pacholke, MD
AU  - Janardhana Ponnatapura, MD
AU  - Kathryn E. Weaver, PhD
AU  - Glenn J. Lesser, MD
AU  - Sun H. Park, PhD
AU  - Jeffrey S. Willey, PhD
AU  - Michael K. Farris, MD
PY  - 2026
DA  - 2026/08/31
JO  - JTO Clinical and Research Reports
DO  - 10.1016/j.jtocrr.2026.101069
UR  - https://doi.org/10.1016/j.jtocrr.2026.101069
AB  - Introduction: Stereotactic body radiotherapy (SBRT) to peripheral lung tumors is associated with radiation-induced bone effects that may predispose patients to chest wall pain and radiation-induced rib fractures. These effects may be inhibited by bisphosphonates. We aimed to determine the impact of risedronate on the radiologic biomarker of rib cortical thickness (CTh) in patients with peripheral lung tumors treated with SBRT. Methods: This randomized, double-blind, placebo-controlled phase 2 clinical trial enrolled patients with tumors within 2 cm of the chest wall, who were randomized 1:1 to receive risedronate 150 mg prior to SBRT or placebo. CTh was evaluated every 3 months for 1 year. The primary endpoint was the percent change in rib CTh from baseline to 3 months within the higher than 30 Gy isodose region. Results: Seventy-three patients (78 tumors) were randomized and eligible for analysis. Baseline CTh was 1.46 (± 0.34) mm and 1.44 (± 0.42) mm in the placebo and risedronate arms, respectively. The mean percent change from baseline to 3 months within the 30 Gy isodose region was 6.4% (± 18.0) for placebo versus 3.1% (± 17.9) for risedronate (absolute difference: −3.3%; p = 0.44). The absolute differences in percent CTh change from baseline to 6, 9, and 12 months in the risedronate (versus placebo) group were −4.7%, −8.3%, and −11.8%, respectively. Conclusion: In patients with peripheral lung tumors treated with SBRT, risedronate did not result in statistically significant differences in CTh within the 30 Gy isodose region. This biomarker of bone changes after SBRT demonstrated increases over time within higher dose regions in the placebo group but remained similar to baseline in the risedronate group. Further studies are needed.
SN  - 2666-3643
ER  -