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

Recruiting

• Conditions: Breast Cancer
• Interventions: Other: Physical Evaluation; Diagnostic Test: Dual-energy X-ray absorptiometry scans; Diagnostic Test: Trabecular Bone Score

• Registration Number: NCT05590949
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-18
• Study First Submitted: 2022-10-18
• Study First Submitted QC: 2022-10-20
• Study First Posted: 2022-10-21
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-15
• Last Update Posted: 2025-05-20
• Primary Completion: 2025-10-18
• Study Completion: 2025-10-18

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 100

Inclusion 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

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Post- menopausal breast cancer patients	Dual-energy X-ray absorptiometry scans	Participants are post- menopausal with a breast cancer diagnosis who received at least 2 doses of denosumab, and then discontinued therapy, and discontinued Aromatase Inhibitors/AI prior to or within 6 months of stopping denosumab
Post- menopausal breast cancer patients	Trabecular Bone Score	Participants are post- menopausal with a breast cancer diagnosis who received at least 2 doses of denosumab, and then discontinued therapy, and discontinued Aromatase Inhibitors/AI prior to or within 6 months of stopping denosumab
Post- menopausal breast cancer patients	Physical Evaluation	Participants are post- menopausal with a breast cancer diagnosis who received at least 2 doses of denosumab, and then discontinued therapy, and discontinued Aromatase Inhibitors/AI prior to or within 6 months of stopping denosumab

Primary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (7)

Memorial Sloan Kettering Westchester (Limited Protocol Activities); 🇺🇸 Harrison, New York, United States

Memorial Sloan Kettering Nassau (Limited Protocol Activities); 🇺🇸 Uniondale, New York, United States

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

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

Memorial Sloan Kettering Monmouth (Limited Protocol Activities); 🇺🇸 Middletown, New Jersey, United States

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities); 🇺🇸 Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Bergen (Limited Protocol Activities); 🇺🇸 Montvale, New Jersey, United States