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Registry of Adjuvant Hormone-blockade Breast Cancer Patients Evaluated for Bone Mineral Metabolism

NCT06773533 · IRCCS Azienda Ospedaliero-Universitaria di Bologna
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Official title
Establishment of a Registry of Adjuvant Hormone-blockade Breast Cancer Patients Evaluated for Bone Mineral Metabolism
About this study
Establishment of a registry by which to census all patients treated with adjuvant hormone blockade for previous breast cancer in order to evaluate in future studies the trend of bone mass and its relationship to laboratoristic indices inherent in calcium metabolism, and the prevalence and incidence of fractures. Inclusion in the registry will be proposed consecutively to every patient with adjuvant hormone-blockade breast cancer diagnosed and evaluated at the Endocrinology Operative Unit for Bone Mineral Metabolism as part of the 'Diagnostic Clinical-Assistance Pathway (PDTA) of the patient with breast cancer' of IRCCS AOU of Bologna and referred/referred by Zamagni Oncology. The registry will include patients seen from 01/01/2015 for a duration of 15 years. A maximum follow-up duration for each patient is expected to be 10 years with an end date of enrollment on 12/31/2029 and a registry update deadline on 12/31/2039.
Eligibility 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
Study design
Enrollment target: 3000 participants
Age groups: adult, older_adult
Timeline
Starts: 2021-12-18
Estimated completion: 2039-12-31
Last updated: 2025-01-14
Primary outcomes
  • Establishment of a Registry for Patients Treated with Adjuvant Hormone Blockade for Breast Cancer: Evaluation of Bone Mass, Calcium Metabolism Indices, and Fracture Incidence (through study completion, an average of 15 years)
Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna · other
Contacts & investigators
ContactUberto Pagotto, MD · contact · uberto.pagotto@unibo.it · +390512144190
InvestigatorUberto Pagotto, MD · principal_investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
All locations (1)
IRCCS Azienda Ospedaliero-Universitaria di BolognaRecruiting
Bologna, Bologna, Italy
Registry of Adjuvant Hormone-blockade Breast Cancer Patients Evaluated for Bone Mineral Metabolism · TrialPath