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ID07555210

Study of Bone Density Changes in Adults Receiving Anti-PD-1 Immunotherapy for Cancer

Led by Jessica Mezzanotte Sharpe · Updated on 2026-05-06

25

Participants Needed

1

Research Sites

26 weeks

Total Duration

AI-Summary

What this Trial Is About

Immune checkpoint inhibitors ICIs are a type of cancer treatment that help the immune system recognize and attack cancer cells. They are approved for many cancers and stages but can cause inflammation and damage in organs, sometimes leading to serious complications. This research focuses on how ICIs might weaken bones and increase fracture risk, which is a growing concern as more patients receive these therapies. The study aims to better understand bone changes in patients receiving ICIs to help improve monitoring and care in the future. Participants will undergo bone density scans using two devices Dual-Energy X-ray Absorptiometry DXA and High Resolution peripheral Quantitative Computed Tomography HRpQCT. These scans will be done three times before or within one month of starting ICI treatment, at 4 to 6 months during treatment, and after 12 months of immunotherapy. The study includes patients treated with anti-PD-1 immunotherapy alone or combined with chemotherapy for curative intent. During the study, researchers will track changes in bone mineral density, bone structure, and blood markers related to bone health at these three time points. They will also monitor fractures and immune-related side effects during the 12-month treatment period. This will help measure how ICI therapy affects bone strength and risks. The total participation time is about one year, with scans and blood tests to evaluate bone health and safety throughout the treatment.

CONDITIONS

Brief Title

Pilot Study of Bone Mineral Density Changes During Anti-PD-1 Immunotherapy

Research Team

J

Jessica Sharpe, MD, PhD

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