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Observational Study of Bone Complications in People With Post-menopausal Breast Cancer Who Have Stopped Treatment With Denosumab and Aromatase Inhibitors
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
Who can join
Ages 18 and older · Women
Full eligibility criteria
Inclusion Criteria: * Women with Stage 0-3 breast cancer confirmed at MSKCC * Currently have no clinical evidence of disease * 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.
About the study
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.
What is being tested
- Physical Evaluation (other)
- Dual-energy X-ray absorptiometry scans (diagnostic test)
- Trabecular Bone Score (diagnostic test)
Sponsor: Memorial Sloan Kettering Cancer Center · Participants: 100 · Started: Oct 18, 2022
Contact the study team
- Monica Fornier, MD · Phone: 646-888-4563
- Azeez Farooki, MD · Phone: 646-608-3798
Official record on ClinicalTrials.gov — NCT05590949
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.