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

What this trial studies

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 in scope

• Breast Cancer

Interventions

• Physical Evaluation (Other) — 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…
• Dual-energy X-ray absorptiometry scans (Diagnostic Test) — 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 (Diagnostic Test) — 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…

Who can join

Women only · Ages 18 Years and up

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.

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Recruiting
• Study type: Observational
• Phase: N/A
• Start date: 2022-10-18
• Primary completion: 2026-10-18
• Last update posted: 2025-08-22
• First posted: 2022-10-21

Sponsor & contact

Lead sponsor: Memorial Sloan Kettering Cancer Center (Other)

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• 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)

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