Actively Recruiting

Age: 18Years +
FEMALE
NCT05590949

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

Led by Memorial Sloan Kettering Cancer Center · Updated on 2025-08-22

100

Participants Needed

7

Research Sites

208 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Women with confirmed diagnosis of breast cancer
  • 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 aromatase inhibitor therapy prior to or within 6 months of last denosumab injection
  • 18 years of age or older
Not Eligible

You will not qualify if you...

  • History of osteoporosis before starting denosumab, based on previous DEXA scan
  • History of insufficiency fracture
  • Continuing treatment with other bone modifying agents after stopping denosumab
  • Use of chronic low-dose glucocorticoids

AI-Screening

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Trial Site Locations

Total: 7 locations

1

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, United States, 07920

Actively Recruiting

2

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, United States, 07748

Actively Recruiting

3

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, United States, 07645

Actively Recruiting

4

Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activities)

Commack, New York, United States, 11725

Actively Recruiting

5

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, United States, 10604

Actively Recruiting

6

Memorial Sloan Kettering Cancer Center

New York, New York, United States, 10065

Actively Recruiting

7

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Uniondale, New York, United States, 11553

Actively Recruiting

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Research Team

M

Monica Fornier, MD

CONTACT

A

Azeez Farooki, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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