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

Description

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

Breast Cancer
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Related Conditions:

Breast Cancer

Study Overview

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Study Details

Study overview

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.

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

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

Condition
Breast Cancer
Intervention / Treatment

-

Contacts and Locations

Basking Ridge

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities), Basking Ridge, New Jersey, United States, 07920

Middletown

Memorial Sloan Kettering Monmouth (Limited Protocol Activities), Middletown, New Jersey, United States, 07748

Montvale

Memorial Sloan Kettering Bergen (Limited Protocol Activities), Montvale, New Jersey, United States, 07645

Commack

Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activities), Commack, New York, United States, 11725

Harrison

Memorial Sloan Kettering Westchester (Limited Protocol Activities), Harrison, New York, United States, 10604

New York

Memorial Sloan Kettering Cancer Center, New York, New York, United States, 10065

Uniondale

Memorial Sloan Kettering Nassau (Limited Protocol Activities), Uniondale, New York, United States, 11553

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Memorial Sloan Kettering Cancer Center,

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

Study Record Dates

2025-10-18