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

ConditionBreast Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorMemorial Sloan Kettering Cancer Center

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

Treatment groups

100 Participants
are divided into 1 treatment group