Health and QoL in Oncological Patients: Management of Bone Pathology in Italian Citbl Population
Health and Quality of Life in Oncological Patients: Management of Bone Pathology in the Italian Citbl (Cancer Treatment Induced Bone Loss) Population
1 other identifier
observational
700
1 country
1
Brief Summary
Studying the current state of the clinical approaches to bone diseases in breast cancer patients treated with adjuvant and/or hormone therapy
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2018
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 26, 2018
CompletedFirst Submitted
Initial submission to the registry
March 11, 2019
CompletedFirst Posted
Study publicly available on registry
August 14, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 26, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 26, 2021
CompletedFebruary 17, 2020
February 1, 2020
2.4 years
March 11, 2019
February 13, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (7)
Fondazione Policlinico Universitario A. Gemelli, Roma
Polo Scienze della Salute della Donna e del Bambino
Università degli Studi di Pavia
Università di Napoli "Federico II"
Università degli Studi di Siena
Azienda Ospedaliero-Universitaria Careggi Firenze
Fondazione Policlinico Universitario A. Gemelli Roma
U.O.C Chirurgia Senologica
Istituto Nazionale dei Tumori di Napoli Fondazione G.Pascale
Interventions
Studying the current state of the clinical approaches to bone diseases in breast cancer patients treated with adjuvant and/or hormone therapy
Eligibility Criteria
Women affected by breast cancer in menopause or with secondary amenorrhea arising from the initiation of oncologic treatments
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Policlinico Agostino Gemelli
Roma, RM, 00168, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
March 11, 2019
First Posted
August 14, 2019
Study Start
July 26, 2018
Primary Completion
December 26, 2020
Study Completion
October 26, 2021
Last Updated
February 17, 2020
Record last verified: 2020-02