Registry for breast cancer patients on hormone therapy and bone health
Establishment of a Registry of Adjuvant Hormone-blockade Breast Cancer Patients Evaluated for Bone Mineral Metabolism
This study is tracking breast cancer patients on hormone therapy to see how it affects their bone health and the risk of fractures over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 3000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna Academic / other |
| Locations | 1 site (Bologna, Bologna) |
| Trial ID | NCT06773533 on ClinicalTrials.gov |
What this trial studies
This registry aims to collect data from patients who have undergone adjuvant hormone blockade therapy for breast cancer. It will evaluate trends in bone mass and its relationship to calcium metabolism indices, as well as track the prevalence and incidence of fractures over time. Patients will be enrolled consecutively at the Endocrinology Operative Unit for Bone Mineral Metabolism in Bologna, with a follow-up period of up to 10 years. The registry will include patients diagnosed from January 1, 2015, until December 31, 2029, with updates continuing until December 31, 2039.
Who should consider this trial
Good fit: Ideal candidates are adult patients aged 18 and older who are undergoing adjuvant hormone blockade therapy for breast cancer.
Not a fit: Patients not receiving hormone blockade therapy for breast cancer may not benefit from this registry.
Why it matters
Potential benefit: If successful, this registry could provide valuable insights into the long-term effects of hormone blockade therapy on bone health in breast cancer patients.
How similar studies have performed: While similar studies have explored the effects of hormone therapy on bone health, this specific registry approach is novel in its comprehensive long-term tracking.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years * Patient undergoing adjuvant hormone blockade therapy (aromatase inhibitors, GnRH analogs, tamoxifen) for breast cancer referred by UO Oncology Zamagni * Performed densitometry at UO Radiology Lovato and performed hematochemical tests inherent to mineral metabolism * Informed consent obtained Exclusion Criteria: * none
Where this trial is running
Bologna, Bologna
- IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna, Bologna, Italy (Recruiting)
Study contacts
- Principal investigator: Uberto Pagotto, MD — IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Study coordinator: Uberto Pagotto, MD
- Email: uberto.pagotto@unibo.it
- Phone: +390512144190
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.