An Observational Study of Bone Complications in People With Post-menopausal Breast Cancer Who Stopped Treatment With Denosumab and Aromatase Inhibitors

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Full Title

Post-menopausal Breast Cancer Patients Treated with Aromatase-inhibitors and Denosumab: An Observational Study to Assess Rebound Bone Loss and Insufficiency Fractures after Denosumab Discontinuation

Purpose

Aromatase inhibitors (AIs) are medications that interfere with estrogen production and are used to reduce the risk of breast cancer recurrence in many people with breast cancer that is fueled by estrogen. One side effect of AI treatment is a decrease in bone strength, which can lead to bones becoming weak and brittle. The bones may then break (fracture) more easily.

Denosumab is a drug used to combat bone loss and reduce fracture risk. However, once denosumab is stopped, the bone mass gained during therapy may be lost.

Researchers are conducting the current study to gather information about changes in the bones in people who have stopped treatment with AI and denosumab for post-menopausal breast cancer. They will collect information from routine health assessments, blood tests, and imaging exams to improve the understanding of how and when bone changes occur and learn more about how to treat post-menopausal breast cancer in the future.

Who Can Join

This study includes women with post-menopausal breast cancer who stopped treatment with AIs and denosumab.

Contact

For more information about this study, please contact Dr. Monica Fornier at 646-888-5240.

Protocol

22-280

Investigator

Co-Investigators

Jennifer Cagney

ClinicalTrials.gov ID

NCT05590949