Breast Cancer
Conditions
Keywords
Post-menopausal Breast Cancer, Breast Cancer, Denosumab, Aromatase, 22-280, Memorial Sloan Kettering Cancer Center
Brief 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.
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.
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Women with Stage 0-3 breast cancer confirmed at MSKCC * Currently have no clinical evidence of disease * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in serum carboxy-terminal collagen crosslinks (CTX) | 12 months | Evaluate changes in bone turnover markers at 12 months after the last dose of denosumab - serum carboxy-terminal collagen crosslinks (CTX) |
| Change in bone specific alkaline phosphatase (ALK) | 12 months | Evaluate changes in bone turnover markers at 12 months after the last dose of denosumab - bone specific alkaline phosphatase (ALK) |
Countries
United States
Contacts
CONTACTMonica Fornier, MD
CONTACTAzeez Farooki, MD
PRINCIPAL_INVESTIGATORMonica Fornier, MD
Memorial Sloan Kettering Cancer Center
Outcome results
None listed