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NCT05590949Recruiting

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

Memorial Sloan Kettering Cancer Center

Start Date

10/18/2022

Completion Date

10/18/2026

Summary

The purpose of this study to gather information about changes in the bones after stopping treatment with aromatase inhibitor/AI and denosumab. The study team will collect information from 5 standard clinic visits over the course of 24 months. The information will include information about participant health assessments, blood test results, and imaging results. After 24 months, participation in this study will be complete.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Women with confirmed diagnosis of breast cancer * Participant must be post-menopausal, defined as last menstrual cycle at least 12 months prior to enrollment * Received at least 2 doses of denosumab and then discontinued therapy * Discontinued AI prior to or within 6 months of last denosumab injection * Patients must be 18 years of age or olde Exclusion Criteria: * Patients with history of osteoporosis prior to starting denosumab, based on previous dual-energy X-ray absorptiometry (DEXA) scan; * Patients with history of insufficiency fracture. * Patients who continue treatment with a different bone modifying agent (i.e oral or intravenous bisphosphonates) after discontinuation of denosumab * Patients on chronic low-dose glucosteroids.

Interventions

OTHER

Physical Evaluation

DIAGNOSTIC_TEST

Dual-energy X-ray absorptiometry scans

DIAGNOSTIC_TEST

Trabecular Bone Score

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Conditions

Breast Cancer

Locations

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey 07920

United States

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey 07748

United States

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey 07645

United States

Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activities)

Commack, New York 11725

United States

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York 10604

United States

Memorial Sloan Kettering Cancer Center

New York, New York 10065

United States

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Uniondale, New York 11553

United States