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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Breast Cancer

Intervention / Treatment
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* Other: Physical Evaluation
* Diagnostic Test: Dual-energy X-ray absorptiometry scans
* Diagnostic Test: Trabecular Bone Score


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Post- menopausal breast cancer patients<br>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<br>* 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).<br>Diagnostic Test: Dual-energy X-ray absorptiometry scans<br>* Dual-energy X-ray absorptiometry (DEXA) scans will be performed at the 12 months timepoint , and then at the 24 month timepoint.<br>* Other names: DEXA scans;Diagnostic Test: Trabecular Bone Score<br>* 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.<br>* Other names: TBS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in serum carboxy-terminal collagen crosslinks (CTX) | Evaluate changes in bone turnover markers at 12 months after the last dose of denosumab - serum carboxy-terminal collagen crosslinks (CTX) | 12 months | 
| Change in bone specific alkaline phosphatase (ALK) | Evaluate changes in bone turnover markers at 12 months after the last dose of denosumab - bone specific alkaline phosphatase (ALK) | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Post-menopausal Breast Cancer, Breast Cancer, Denosumab, Aromatase, 22-280, Memorial Sloan Kettering Cancer Center