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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

NCT05590949

RecruitingN/A

Sponsor: Memorial Sloan Kettering Cancer Center

Conditions: Breast Cancer

Interventions: Physical Evaluation, Dual-energy X-ray absorptiometry scans, Trabecular Bone Score

Countries: United States

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 overview

Sex: FEMALE

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

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.

Locations (7)

Basking Ridge, New Jersey, United States
Middletown, New Jersey, United States
Montvale, New Jersey, United States
Commack, New York, United States
Harrison, New York, United States
New York, New York, United States
Uniondale, New York, United States