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

RecruitingOBSERVATIONAL
Enrollment

100

Participants

Timeline

Start Date

October 18, 2022

Primary Completion Date

October 18, 2026

Study Completion Date

October 18, 2026

Conditions
Breast Cancer
Interventions
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.

Trial Locations (7)

10065

RECRUITING

Memorial Sloan Kettering Cancer Center, New York

10604

RECRUITING

Memorial Sloan Kettering Westchester (Limited Protocol Activities), Harrison

11553

RECRUITING

Memorial Sloan Kettering Nassau (Limited Protocol Activities), Uniondale

11725

RECRUITING

Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activities), Commack

07920

RECRUITING

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities), Basking Ridge

07748

RECRUITING

Memorial Sloan Kettering Monmouth (Limited Protocol Activities), Middletown

07645

RECRUITING

Memorial Sloan Kettering Bergen (Limited Protocol Activities), Montvale

All Listed Sponsors
lead

Memorial Sloan Kettering Cancer Center

OTHER