RECRUITING

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

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Conditions

Breast CancerPost-menopausal Breast CancerDenosumabAromatase22-280Memorial Sloan Kettering Cancer Center

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

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

Quick Facts

Study Start:2022-10-18
Study Completion:2025-10-18
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05590949

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Women with confirmed diagnosis of breast cancer
  2. * Participant must be post-menopausal, defined as last menstrual cycle at least 12 months prior to enrollment
  3. * Received at least 2 doses of denosumab and then discontinued therapy
  4. * Discontinued AI prior to or within 6 months of last denosumab injection
  5. * Patients must be 18 years of age or olde
  1. * Patients with history of osteoporosis prior to starting denosumab, based on previous dual-energy X-ray absorptiometry (DEXA) scan;
  2. * Patients with history of insufficiency fracture.
  3. * Patients who continue treatment with a different bone modifying agent (i.e oral or intravenous bisphosphonates) after discontinuation of denosumab
  4. * Patients on chronic low-dose glucosteroids.

Contacts and Locations

Study Contact

Monica Fornier, MD
CONTACT
646-888-4563
fornierm@mskcc.org
Azeez Farooki, MD
CONTACT
646-608-3798
farookia@mskcc.org

Principal Investigator

Monica Fornier, MD
PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center

Study Locations (Sites)

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, 07920
United States
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, 07748
United States
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, 07645
United States
Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activities)
Commack, New York, 11725
United States
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, 10604
United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
United States
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, 11553
United States

Collaborators and Investigators

Sponsor: Memorial Sloan Kettering Cancer Center

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-10-18
Study Completion Date2025-10-18

Study Record Updates

Study Start Date2022-10-18
Study Completion Date2025-10-18

Terms related to this study

Keywords Provided by Researchers

  • Post-menopausal Breast Cancer
  • Breast Cancer
  • Denosumab
  • Aromatase
  • 22-280
  • Memorial Sloan Kettering Cancer Center

Additional Relevant MeSH Terms

  • Breast Cancer