About this trial
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
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Physical Evaluation
- Dual-energy X-ray absorptiometry scans
- Trabecular Bone Score