RecruitingNCT05590949

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

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

Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

100 participants

Start Date

Oct 18, 2022

Study Type

OBSERVATIONAL

Conditions

Breast Cancer

Summary

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

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria5

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 Criteria4

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.

Interventions

OTHERPhysical 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_TESTDual-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.

DIAGNOSTIC_TESTTrabecular 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.