Bone Complications in Post-menopausal Breast Cancer Patients
Observational Study of Bone Complications in People With Post-menopausal Breast Cancer Who Have Stopped Treatment With Denosumab and Aromatase Inhibitors
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Female
Study type
Observational
Participants needed
100 (estimated)
Sponsor
Memorial Sloan Kettering Cancer Center · Other
Who this trial is looking for
This trial is looking for women who have been treated for breast cancer and have stopped their medications. Participants will provide health information over 24 months to study changes in their bones after stopping treatment.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with breast cancer.
I am post-menopausal.
I have received at least 2 doses of denosumab.
I stopped taking aromatase inhibitors within 6 months of my last denosumab injection.
I am 18 years of age or older.
You may not be able to join if
I have a history of osteoporosis before starting denosumab.
I have a history of insufficiency fracture.
I am still taking a different bone modifying agent after stopping denosumab.
I am on chronic low-dose glucosteroids.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 thi…
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.
Trial Locations
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Eligibility Criteria
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 t…
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.
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