Health and QoL in Oncological Patients: Management of Bone Pathology in Italian Citbl Population

Study Overview
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Brief Summary
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Studying the current state of the clinical approaches to bone diseases in breast cancer patients treated with adjuvant and/or hormone therapy

Official Title
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Health and Quality of Life in Oncological Patients: Management of Bone Pathology in the Italian Citbl (Cancer Treatment Induced Bone Loss) Population

Conditions
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Osteoporosis, Breast Cancer Female

Intervention / Treatment
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* Behavioral: Observational Analysis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients willing to provide the Informed consent to participate to the study Women aged 18-75 years Patients having breast cancer, with no phenotype restrictions Patients in natural and stable menopause Patients having secondary amenorrhea, that arose after the initiation of oncologic treatment, since at least 12 months or 6 months with FSH> 40 U/I Exclusion Criteria: Patients with advanced cancer and/or bone metastases and/or visceral metastases Patients with severe renal insufficiency and/or in dialysis and patients affected by severe endocrine disorders

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Fondazione Policlinico Universitario A. Gemelli, Roma<br>Polo Scienze della Salute della Donna e del Bambino | Behavioral: Observational Analysis<br>* Studying the current state of the clinical approaches to bone diseases in breast cancer patients treated with adjuvant and/or hormone therapy<br>|
| Università degli Studi di Pavia<br> | Behavioral: Observational Analysis<br>* Studying the current state of the clinical approaches to bone diseases in breast cancer patients treated with adjuvant and/or hormone therapy<br>|
| Università di Napoli Federico II<br> | Behavioral: Observational Analysis<br>* Studying the current state of the clinical approaches to bone diseases in breast cancer patients treated with adjuvant and/or hormone therapy<br>|
| Università degli Studi di Siena<br> | Behavioral: Observational Analysis<br>* Studying the current state of the clinical approaches to bone diseases in breast cancer patients treated with adjuvant and/or hormone therapy<br>|
| Azienda Ospedaliero-Universitaria Careggi Firenze<br> | Behavioral: Observational Analysis<br>* Studying the current state of the clinical approaches to bone diseases in breast cancer patients treated with adjuvant and/or hormone therapy<br>|
| Fondazione Policlinico Universitario A. Gemelli Roma<br>U.O.C Chirurgia Senologica | Behavioral: Observational Analysis<br>* Studying the current state of the clinical approaches to bone diseases in breast cancer patients treated with adjuvant and/or hormone therapy<br>|
| Istituto Nazionale dei Tumori di Napoli Fondazione G.Pascale<br> | Behavioral: Observational Analysis<br>* Studying the current state of the clinical approaches to bone diseases in breast cancer patients treated with adjuvant and/or hormone therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Results from some questionnaires related to patients QoL, rated from 1 to 10. | Description of the current state of the most frequent clinical and therapeutical approaches to bone diseases in 700 breast cancer menopausal patients treated with adjuvant and/or hormonal therapy. These patients are assessed by questionnaires regarding quality of life, menopausal status and current anti resorptive treatments | 26-32 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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QoL, Aromatase Inhibitors, Bone pathology