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

Conditions

• Breast Cancer

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

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 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 — 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 with bone density measured by DEXA has been shown to be superior to either measurement alone in the assessment of fracture risk.

Study Details

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.

Key Dates

Start date

Oct 18, 2022

Status verified

Aug 2025

Primary completion

Oct 18, 2026

Completion

Oct 18, 2026

Study Design

Enrollment

100 participants (estimated)

Arms

• Arm: 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

Primary Outcome Measure

Change in serum carboxy-terminal collagen crosslinks (CTX) [ Time Frame: 12 months ]

Central Contacts

• Monica Fornier, MD
  646-888-4563
  [email protected]
• Azeez Farooki, MD
  646-608-3798
  [email protected]

Locations (7)

Find similar trials in Basking Ridge, NJ

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