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

• Conditions: Osteoporosis; Breast Cancer Female
• Interventions: Behavioral: Observational Analysis

• Registration Number: NCT04055805
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2018-07-26
• Study First Submitted: 2019-03-11
• Study First Submitted QC: 2019-08-10
• Study First Posted: 2019-08-14
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-13
• Last Update Posted: 2020-02-17
• Primary Completion: 2020-12-26
• Study Completion: 2021-10-26

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 700

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Fondazione Policlinico Universitario A. Gemelli Roma	Observational Analysis	U.O.C Chirurgia Senologica
Università di Napoli "Federico II"	Observational Analysis	-
Fondazione Policlinico Universitario A. Gemelli, Roma	Observational Analysis	Polo Scienze della Salute della Donna e del Bambino
Università degli Studi di Pavia	Observational Analysis	-
Università degli Studi di Siena	Observational Analysis	-
Azienda Ospedaliero-Universitaria Careggi Firenze	Observational Analysis	-
Istituto Nazionale dei Tumori di Napoli Fondazione G.Pascale	Observational Analysis	-

Primary Outcome Measures

Name	Time	Method
Results from some questionnaires related to patients QoL, rated from 1 to 10.	26-32 months	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

Trial Locations

Locations (1)

Policlinico Agostino Gemelli; 🇮🇹 Roma, RM, Italy