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Recruiting NCT05590949

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

— Observational Breast Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Physical Evaluation, Dual-energy X-ray absorptiometry scans, Trabecular Bone Score.
Who it may be relevant to
Registry conditions: Breast Cancer. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Post-menopausal Breast Cancer Patients Treated With Aromatase Inhibitors and Denosumab: An Observational Study to Assess Rebound Bone Loss and Insufficiency Fractures After Denosumab Discontinuation

Overview

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.

Interventions

  • Other 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 dr
  • Diagnostic test 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.
  • Diagnostic test 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 measures

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

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 7 centers
  • Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) — Basking Ridge
  • Memorial Sloan Kettering Monmouth (Limited Protocol Activities) — Middletown
  • Memorial Sloan Kettering Bergen (Limited Protocol Activities) — Montvale
  • Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activities) — Commack
  • Memorial Sloan Kettering Westchester (Limited Protocol Activities) — Harrison
  • Memorial Sloan Kettering Cancer Center — New York
  • Memorial Sloan Kettering Nassau (Limited Protocol Activities) — Uniondale

Identifiers

NCT: NCT05590949 · 22-280

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗