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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 5 visits
  • Procedures mentioned: Blood draws

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tracks bone changes in women with breast cancer after menopause who have stopped denosumab and aromatase inhibitors (AI). The study team will collect health checks, blood test results, and imaging results from 5 regular clinic visits over 24 months.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Women age 18 or older.
  • Had stage 0–3 breast cancer confirmed at MSKCC.
  • Have no current signs of breast cancer on medical checks.
  • Had their last period at least 12 months before joining.
  • Received at least 2 doses of denosumab and then stopped it.
  • Stopped AI treatment before or within 6 months after their last denosumab shot.

Who can't join

  • Had osteoporosis (weak bones) before starting denosumab, shown by a DEXA bone density scan.
  • Have had an insufficiency fracture (a break caused by normal stress on a weak bone).
  • Continue taking another bone-treating drug after stopping denosumab, such as bisphosphonates taken by mouth or through a vein.
  • Take low-dose glucocorticoids (steroid medicines) long term.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (7)

NJ

NY