Dysautonomia International

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

Purpose

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.

Condition

Breast Cancer

Eligibility

Eligible Ages: Over 18 Years
Eligible Sex: Female
Accepts Healthy Volunteers: No

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.

Study Design

Phase
Study Type: Observational
Observational Model: Cohort
Time Perspective: Prospective

Arm Groups

Arm	Description	Assigned Intervention
Post- menopausal breast cancer patients	Participants are post- menopausal with a breast cancer diagnosis who received at least 2 doses of denosumab, and then discontinued therapy, and discontinued Aromatase Inhibitors/AI prior to or within 6 months of stopping denosumab	Other: Physical Evaluation Participants will be assessed at Timepoint 0 (last dose of denosumab injection) and then at 9,12,18 and 24 months following discontinuation of denosumab. The evaluation will include history and pain assessment for development of new fractures, weight and height measurement with BMI (body mass index) calculation, and blood work for bone turnover markers (including serum carboxy-terminal collagen crosslinks (CTX) in serum and bone specific alkaline phosphatase). Bone turn-over markers should be drawn in the morning, after at least 8 hours of fasting (water, black coffee and plain tea allowed). Diagnostic Test: Dual-energy X-ray absorptiometry scans Dual-energy X-ray absorptiometry (DEXA) scans will be performed at the 12 months timepoint , and then at the 24 month timepoint. Other names: DEXA scans Diagnostic Test: Trabecular Bone Score TBS is an innovative gray-level texture measurement that utilizes lumbar spine DEXA images to discriminate changes in bone microarchitecture. Specifically, TBS measures bone quality through tridimensional bone areas with different trabecular and microstructural characteristics. The combination of TBS microstructure evaluation with bone density measured by DEXA has been shown to be superior to either measurement alone in the assessment of fracture risk. Other names: TBS

Recruiting Locations

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey 07920