Recruiting

Observational Study

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT05590949

Conditions

Breast Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Physical Evaluation

Dual-energy X-ray absorptiometry scans

Trabecular Bone Score

Study Details

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.

Conditions

Breast Cancer

Study ID

NCT05590949

Start date

Oct 18, 2022

Status verified date

Sep, 2026

Completion date

Oct 18, 2026

Anticipated

Primary completion date

Oct 18, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Women with Stage 0-3 breast cancer confirmed at MSKCC
  • Currently have no clinical evidence of disease
  • 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

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Interventions

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.

Primary outcome measure

  • Change in serum carboxy-terminal collagen crosslinks (CTX) [ Time Frame: 12 months ]
  • Change in bone specific alkaline phosphatase (ALK) [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Locations

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Recruiting

Basking Ridge, New Jersey, United States, 07920

Contacts

Monica Fornier, MD

646-888-4563

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Recruiting

Middletown, New Jersey, United States, 07748

Contacts

Monica Fornier, MD

646-888-4563

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Recruiting

Montvale, New Jersey, United States, 07645

Contacts

Monica Fornier, MD

646-888-4563

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

Recruiting

Commack, New York, United States, 11725

Contacts

Monica Fornier, MD

646-888-4563

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Recruiting

Harrison, New York, United States, 10604

Contacts

Monica Fornier, MD

646-888-4563

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

Monica Fornier, MD

646-888-5240

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Recruiting

Uniondale, New York, United States, 11553

Contacts

Monica Fornier, MD

646-888-4563

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

Sep 3, 2026

Last verified

Sep, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2026-09-03.