100
Participants
Start Date
October 18, 2022
Primary Completion Date
October 18, 2026
Study Completion Date
October 18, 2026
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).
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.
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.
RECRUITING
Memorial Sloan Kettering Cancer Center, New York
RECRUITING
Memorial Sloan Kettering Westchester (Limited Protocol Activities), Harrison
RECRUITING
Memorial Sloan Kettering Nassau (Limited Protocol Activities), Uniondale
RECRUITING
Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activities), Commack
RECRUITING
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities), Basking Ridge
RECRUITING
Memorial Sloan Kettering Monmouth (Limited Protocol Activities), Middletown
RECRUITING
Memorial Sloan Kettering Bergen (Limited Protocol Activities), Montvale
Memorial Sloan Kettering Cancer Center
OTHER