Observing bone health in post-menopausal breast cancer patients after stopping certain treatments
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
This study looks at how stopping certain breast cancer treatments affects bone health in post-menopausal women over two years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Memorial Sloan Kettering Cancer Center Academic / other |
| Drugs / interventions | denosumab |
| Locations | 7 sites (Basking Ridge, New Jersey and 6 other locations) |
| Trial ID | NCT05590949 on ClinicalTrials.gov |
What this trial studies
This observational study aims to collect data on bone health changes in post-menopausal women with breast cancer who have discontinued treatment with denosumab and aromatase inhibitors. Participants will undergo health assessments, blood tests, and imaging over five clinic visits spanning 24 months. The study will help understand the impact of stopping these treatments on bone complications. By gathering this information, researchers hope to identify potential risks and inform future treatment strategies.
Who should consider this trial
Good fit: Ideal candidates are post-menopausal women with a confirmed diagnosis of breast cancer who have stopped treatment with denosumab and aromatase inhibitors.
Not a fit: Patients with a history of osteoporosis or insufficiency fractures prior to starting denosumab may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into bone health management for post-menopausal breast cancer patients after stopping specific therapies.
How similar studies have performed: While similar studies have explored bone health in breast cancer patients, this specific observational approach focusing on post-treatment changes is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Basking Ridge, New Jersey and 6 other locations
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) — Basking Ridge, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities) — Middletown, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Bergen (Limited Protocol Activities) — Montvale, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activities) — Commack, New York, United States (Recruiting)
- Memorial Sloan Kettering Westchester (Limited Protocol Activities) — Harrison, New York, United States (Recruiting)
- Memorial Sloan Kettering Cancer Center — New York, New York, United States (Recruiting)
- Memorial Sloan Kettering Nassau (Limited Protocol Activities) — Uniondale, New York, United States (Recruiting)
Study contacts
- Principal investigator: Monica Fornier, MD — Memorial Sloan Kettering Cancer Center
- Study coordinator: Monica Fornier, MD
- Email: fornierm@mskcc.org
- Phone: 646-888-4563
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.