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Observational Study of Bone Health After Stopping Denosumab and Aromatase Inhibitors for Breast Cancer

This study is looking at how bones change in women with post-menopausal breast cancer after they stop taking denosumab and aromatase inhibitors (AI). Researchers want to understand if these changes lead to bone problems. You may be able to join if you are a post-menopausal woman with breast cancer who has stopped taking denosumab and AI. The study will involve collecting health information, blood tests, and imaging results over 24 months. The main goal is to measure changes in specific bone markers in your blood after 12 months. The current status of this study is unclear.

Study design
This is an observational study planning to enroll 100 participants. It is not a treatment study but rather collects information about your health over time.
What's involved
You would have 5 clinic visits over 24 months. These visits will include physical evaluations, blood tests, and DEXA scans (a type of bone density scan) at specific time points.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 24 months after stopping denosumab, with specific measurements taken at 9, 12, 18, and 24 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05590949

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

Recruiting
Not specifiedAges 18+Observational
Memorial Sloan Kettering Cancer Center
~100 participants
Updated 2026-08-20 on ClinicalTrials.gov
What's tested:Physical EvaluationDual-energy X-ray absorptiometry scansTrabecular Bone Score

At a glance

Recruiting sites
7 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in serum carboxy-terminal collagen crosslinks (CTX)
Measured over 12 months
+1 more outcome measured

Conditions

Breast Cancer

Explore related trials

Breast Carcinoma

Where it's being run

7 sites across 2 states
New York4
New Jersey3

Study leadership

  • Monica Fornier, MD · PRINCIPAL_INVESTIGATOR · Memorial Sloan Kettering Cancer Center

Who to contact

Monica Fornier, MD
[email protected]
646-888-4563
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • 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)