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

February 13, 2020 updated by: Dr.ssa Paola Villa, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

700

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women affected by breast cancer in menopause or with secondary amenorrhea arising from the initiation of oncologic treatments

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Fondazione Policlinico Universitario A. Gemelli, Roma
Polo Scienze della Salute della Donna e del Bambino
Behavioral: Observational Analysis
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
Behavioral: Observational Analysis
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"
Behavioral: Observational Analysis
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
Behavioral: Observational Analysis
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
Behavioral: Observational Analysis
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
Behavioral: Observational Analysis
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
Behavioral: Observational Analysis
Studying the current state of the clinical approaches to bone diseases in breast cancer patients treated with adjuvant and/or hormone therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Results from some questionnaires related to patients QoL, rated from 1 to 10.
Time Frame: 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
26-32 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 26, 2018

Primary Completion (Anticipated)

December 26, 2020

Study Completion (Anticipated)

October 26, 2021

Study Registration Dates

First Submitted

March 11, 2019

First Submitted That Met QC Criteria

August 10, 2019

First Posted (Actual)

August 14, 2019

Study Record Updates

Last Update Posted (Actual)

February 17, 2020

Last Update Submitted That Met QC Criteria

February 13, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VIL-HEQ-17-014

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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