Observational Study of Bone Complications in People With Post-menopausal Breast Cancer Who Have Stopped Treatment With Denosumab and Aromatase Inhibitors
NCT ID: NCT05590949
Last Updated: 2025-08-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
100 participants
OBSERVATIONAL
2022-10-18
2026-10-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Post- menopausal breast cancer patients
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
Physical Evaluation
Participants will be assessed at Timepoint 0 (last dose of denosumab injection) and then at 9,12,18 and 24 months following discontinuation of denosumab. The evaluation will include history and pain assessment for development of new fractures, weight and height measurement with BMI (body mass index) calculation, and blood work for bone turnover markers (including serum carboxy-terminal collagen crosslinks (CTX) in serum and bone specific alkaline phosphatase). Bone turn-over markers should be drawn in the morning, after at least 8 hours of fasting (water, black coffee and plain tea allowed).
Dual-energy X-ray absorptiometry scans
Dual-energy X-ray absorptiometry (DEXA) scans will be performed at the 12 months timepoint , and then at the 24 month timepoint.
Trabecular Bone Score
TBS is an innovative gray-level texture measurement that utilizes lumbar spine DEXA images to discriminate changes in bone microarchitecture. Specifically, TBS measures bone quality through tridimensional bone areas with different trabecular and microstructural characteristics. The combination of TBS microstructure evaluation with bone density measured by DEXA has been shown to be superior to either measurement alone in the assessment of fracture risk.
Interventions
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Physical Evaluation
Participants will be assessed at Timepoint 0 (last dose of denosumab injection) and then at 9,12,18 and 24 months following discontinuation of denosumab. The evaluation will include history and pain assessment for development of new fractures, weight and height measurement with BMI (body mass index) calculation, and blood work for bone turnover markers (including serum carboxy-terminal collagen crosslinks (CTX) in serum and bone specific alkaline phosphatase). Bone turn-over markers should be drawn in the morning, after at least 8 hours of fasting (water, black coffee and plain tea allowed).
Dual-energy X-ray absorptiometry scans
Dual-energy X-ray absorptiometry (DEXA) scans will be performed at the 12 months timepoint , and then at the 24 month timepoint.
Trabecular Bone Score
TBS is an innovative gray-level texture measurement that utilizes lumbar spine DEXA images to discriminate changes in bone microarchitecture. Specifically, TBS measures bone quality through tridimensional bone areas with different trabecular and microstructural characteristics. The combination of TBS microstructure evaluation with bone density measured by DEXA has been shown to be superior to either measurement alone in the assessment of fracture risk.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
FEMALE
No
Sponsors
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Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Monica Fornier, MD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, United States
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States
Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activities)
Commack, New York, United States
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, United States
Countries
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Central Contacts
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Facility Contacts
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Monica Fornier, MD
Role: primary
Monica Fornier, MD
Role: primary
Monica Fornier, MD
Role: primary
Monica Fornier, MD
Role: primary
Monica Fornier, MD
Role: primary
Monica Fornier, MD
Role: primary
Monica Fornier, MD
Role: primary
Related Links
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Memorial Sloan Kettering Cancer Center
Other Identifiers
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22-280
Identifier Type: -
Identifier Source: org_study_id
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