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

NCT ID: NCT04055805

Last Updated: 2020-02-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

700 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-07-26

Study Completion Date

2021-10-26

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

Detailed Description

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Conditions

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Breast Cancer Female Osteoporosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Fondazione Policlinico Universitario A. Gemelli, Roma

Polo Scienze della Salute della Donna e del Bambino

Observational Analysis

Intervention Type BEHAVIORAL

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

Università degli Studi di Pavia

Observational Analysis

Intervention Type BEHAVIORAL

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

Università di Napoli "Federico II"

Observational Analysis

Intervention Type BEHAVIORAL

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

Università degli Studi di Siena

Observational Analysis

Intervention Type BEHAVIORAL

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

Azienda Ospedaliero-Universitaria Careggi Firenze

Observational Analysis

Intervention Type BEHAVIORAL

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

Fondazione Policlinico Universitario A. Gemelli Roma

U.O.C Chirurgia Senologica

Observational Analysis

Intervention Type BEHAVIORAL

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

Istituto Nazionale dei Tumori di Napoli Fondazione G.Pascale

Observational Analysis

Intervention Type BEHAVIORAL

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

Interventions

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Observational Analysis

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

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role lead

Responsible Party

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Dr.ssa Paola Villa

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Policlinico Agostino Gemelli

Roma, RM, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Paola Villa, Md PhD

Role: CONTACT

+393392318208

Facility Contacts

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Paola Villa, MD, PhD

Role: primary

+393392318208

Other Identifiers

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VIL-HEQ-17-014

Identifier Type: -

Identifier Source: org_study_id

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