NCT05590949

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2022-10-18
• Primary completion: 2026-10-18
• Completion: 2026-10-18
• First posted: 2022-10-21
• Last updated: 2025-08-22

Locations

7 sites across 1 country: United States