Clinical trial Recruiting at 7 sites Observational Ages 18 and up Women only

Observing bone health in post-menopausal breast cancer patients after stopping certain treatments

Official title: Post-menopausal Breast Cancer Patients Treated With Aromatase Inhibitors and Denosumab: An Observational Study to Assess Rebound Bone Loss and Insufficiency Fractures After Denosumab Discontinuation

Run by Memorial Sloan Kettering Cancer Center · NCT05590949 · Data updated 2026-11-12

This study looks at how stopping certain breast cancer treatments affects bone health in post-menopausal women over two years.

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Quick facts

Study typeObservational
Ages18 Years and up
SexWomen only
Enrollment100 (estimated)
SponsorMemorial Sloan Kettering Cancer Center
Academic / other
Drugs / interventionsdenosumab
Locations7 sites (Basking Ridge, New Jersey and 6 other locations)
StatusRecruiting
StartedOctober 18, 2022
Main results expectedOctober 18, 2027
Study endsOctober 18, 2027
Registry record updatedNovember 4, 2026
Trial IDNCT05590949 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are post-menopausal women with a confirmed diagnosis of breast cancer who have stopped treatment with denosumab and aromatase inhibitors.

Probably not a fit

Patients with a history of osteoporosis or insufficiency fractures prior to starting denosumab may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to collect data on bone health changes in post-menopausal women with breast cancer who have discontinued treatment with denosumab and aromatase inhibitors. Participants will undergo health assessments, blood tests, and imaging over five clinic visits spanning 24 months. The study will help understand the impact of stopping these treatments on bone complications. By gathering this information, researchers hope to identify potential risks and inform future treatment strategies.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into bone health management for post-menopausal breast cancer patients after stopping specific therapies.

How similar studies have gone: While similar studies have explored bone health in breast cancer patients, this specific observational approach focusing on post-treatment changes is relatively novel.

Who can join: the full rules

Show full inclusion / exclusion 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 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.

Where it's running

  • Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
    Basking Ridge, New Jersey, United States
    Recruiting
  • Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
    Middletown, New Jersey, United States
    Recruiting
  • Memorial Sloan Kettering Bergen (Limited Protocol Activities)
    Montvale, New Jersey, United States
    Recruiting
  • Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activities)
    Commack, New York, United States
    Recruiting
  • Memorial Sloan Kettering Westchester (Limited Protocol Activities)
    Harrison, New York, United States
    Recruiting
  • Memorial Sloan Kettering Cancer Center
    New York, New York, United States
    Recruiting
Show 1 more location
  • Memorial Sloan Kettering Nassau (Limited Protocol Activities)
    Uniondale, New York, United States
    Recruiting

Study contacts

  • Principal investigator: Monica Fornier, MD — Memorial Sloan Kettering Cancer Center
  • Study coordinator: Monica Fornier, MD
  • Email: fornierm@mskcc.org
  • Phone: 646-888-4563

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.