Breast Cancer FemaleNCT04055805
Health and QoL in Oncological Patients: Management of Bone Pathology in Italian Citbl Population
An observational study of Breast Cancer Female and Osteoporosis, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
Studying the current state of the clinical approaches to bone diseases in breast cancer patients treated with adjuvant and/or hormone therapy Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer Female, Osteoporosis
- What is being tested?
- Observational Analysis
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 700 participants
- Where
- 1 siteItaly
- Study dates
- 26 Jul 2018to 26 Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women affected by breast cancer in menopause or with secondary amenorrhea arising from the initiation of oncologic treatments
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Policlinico Agostino Gemelli
Roma, RM, 00168
Paola Villa, MD, PhD, +393392318208, paola.villa@policlinicogemelli.it
About this study
Official title: 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
- Conditions
- Breast Cancer Female, Osteoporosis
- Being tested
- Observational Analysis
- Keywords
- Aromatase Inhibitors, Bone pathology, QoL
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational AnalysisBehavioural
Studying the current state of the clinical approaches to bone diseases in breast cancer patients treated with adjuvant and/or hormone therapy
| Study group | Role | What they receive |
|---|---|---|
| Fondazione Policlinico Universitario A. Gemelli, Roma | Polo Scienze della Salute della Donna e del Bambino Receives: Behavioral: Observational Analysis | |
| Università degli Studi di Pavia | Not described Receives: Behavioral: Observational Analysis | |
| Università di Napoli "Federico II" | Not described Receives: Behavioral: Observational Analysis | |
| Università degli Studi di Siena | Not described Receives: Behavioral: Observational Analysis | |
| Azienda Ospedaliero-Universitaria Careggi Firenze | Not described Receives: Behavioral: Observational Analysis | |
| Fondazione Policlinico Universitario A. Gemelli Roma | U.O.C Chirurgia Senologica Receives: Behavioral: Observational Analysis | |
| Istituto Nazionale dei Tumori di Napoli Fondazione G.Pascale | Not described Receives: Behavioral: Observational Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 26-32 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2019
- Study start26 Jul 2018
- Primary completion26 Dec 2020 (estimated)
- Study completion26 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer FemaleStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr.ssa Paola Villa, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04055805
- Sponsor's protocol ID
- VIL-HEQ-17-014
- Status last verified
- Feb 2020
- First submitted
- 11 Mar 2019
- Last updated
- 17 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health and Quality of Life in Oncological Patients: Management of Bone Pathology in the Italian Citbl (Cancer Treatment Induced Bone Loss) Population
- ClinicalTrials.gov ID
- NCT04055805
- Acronym / sponsor ID
- VIL-HEQ-17-014
- Conditions
- Breast Cancer Female, Osteoporosis
- Keywords
- Aromatase Inhibitors, Bone pathology, QoL
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 26 Jul 2018 (actual)
- Primary completion
- 26 Dec 2020 (estimated)
- Study completion
- 26 Oct 2021 (estimated)
- First posted
- 14 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Studying the current state of the clinical approaches to bone diseases in breast cancer patients treated with adjuvant and/or hormone therapy
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Fondazione Policlinico Universitario A. Gemelli, Roma | – | Behavioral: Observational AnalysisPolo Scienze della Salute della Donna e del Bambino |
| Università degli Studi di Pavia | – | Behavioral: Observational Analysis |
| Università di Napoli "Federico II" | – | Behavioral: Observational Analysis |
| Università degli Studi di Siena | – | Behavioral: Observational Analysis |
| Azienda Ospedaliero-Universitaria Careggi Firenze | – | Behavioral: Observational Analysis |
| Fondazione Policlinico Universitario A. Gemelli Roma | – | Behavioral: Observational AnalysisU.O.C Chirurgia Senologica |
| Istituto Nazionale dei Tumori di Napoli Fondazione G.Pascale | – | Behavioral: Observational Analysis |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women affected by breast cancer in menopause or with secondary amenorrhea arising from the initiation of oncologic treatments
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational AnalysisStudying the current state of the clinical approaches to bone diseases in breast cancer patients treated with adjuvant and/or hormone therapy | Behavioural | Azienda Ospedaliero-Universitaria Careggi Firenze, Fondazione Policlinico Universitario A. Gemelli Roma, Fondazione Policlinico Universitario A. Gemelli, Roma, Istituto Nazionale dei Tumori di Napoli Fondazione G.Pascale, Università degli Studi di Pavia, Università degli Studi di Siena, Università di Napoli "Federico II" |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer Female and Osteoporosis, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paola Villa, Md PhD (+393392318208, paola.villa@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Results from some questionnaires related to patients QoL, rated from 1 to 10. (time frame: 26-32 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2020; AzTrials last refreshed its copy on 8 Nov 2026.