Trial Title:
Observational Study of Bone Complications in People With Post-menopausal Breast Cancer Who Have Stopped Treatment With Denosumab and Aromatase Inhibitors
NCT ID:
NCT05590949
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
Post-menopausal Breast Cancer
Breast Cancer
Denosumab
Aromatase
22-280
Memorial Sloan Kettering Cancer Center
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
Physical Evaluation
Description:
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).
Arm group label:
Post- menopausal breast cancer patients
Intervention type:
Diagnostic Test
Intervention name:
Dual-energy X-ray absorptiometry scans
Description:
Dual-energy X-ray absorptiometry (DEXA) scans will be performed at the 12 months
timepoint , and then at the 24 month timepoint.
Arm group label:
Post- menopausal breast cancer patients
Other name:
DEXA scans
Intervention type:
Diagnostic Test
Intervention name:
Trabecular Bone Score
Description:
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.
Arm group label:
Post- menopausal breast cancer patients
Other name:
TBS
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.
Criteria for eligibility:
Study pop:
Patients will be recruited through the Breast Medicine and Survivorship Services. Members
of the research team will verify eligibility against the patient's medical record. Once
eligibility is confirmed, and if the treating investigator has no objection to enrolling
the patient in the research study, the patient will be approached for consent. Consent to
the protocol will be conducted by a trained consenting professional. Consent will take
place either in the clinic, or by following the most updated standard working procedures
for consent via telemedicine.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- 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 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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Address:
City:
Basking Ridge
Zip:
07920
Country:
United States
Status:
Recruiting
Contact:
Last name:
Monica Fornier, MD
Phone:
646-888-4563
Facility:
Name:
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Address:
City:
Middletown
Zip:
07748
Country:
United States
Status:
Recruiting
Contact:
Last name:
Monica Fornier, MD
Phone:
646-888-4563
Facility:
Name:
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Address:
City:
Montvale
Zip:
07645
Country:
United States
Status:
Recruiting
Contact:
Last name:
Monica Fornier, MD
Phone:
646-888-4563
Facility:
Name:
Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activities)
Address:
City:
Commack
Zip:
11725
Country:
United States
Status:
Recruiting
Contact:
Last name:
Monica Fornier, MD
Phone:
646-888-4563
Facility:
Name:
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Address:
City:
Harrison
Zip:
10604
Country:
United States
Status:
Recruiting
Contact:
Last name:
Monica Fornier, MD
Phone:
646-888-4563
Facility:
Name:
Memorial Sloan Kettering Cancer Center
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Contact:
Last name:
Monica Fornier, MD
Phone:
646-888-5240
Facility:
Name:
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Address:
City:
Uniondale
Zip:
11553
Country:
United States
Status:
Recruiting
Contact:
Last name:
Monica Fornier, MD
Phone:
646-888-4563
Start date:
October 18, 2022
Completion date:
October 18, 2025
Lead sponsor:
Agency:
Memorial Sloan Kettering Cancer Center
Agency class:
Other
Source:
Memorial Sloan Kettering Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05590949
http://www.mskcc.org
