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

Osteoporosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04055805
• Other study ID #: VIL-HEQ-17-014
• Status: Recruiting
• Start date: July 26, 2018
• Est. completion date: October 26, 2021

Study information

• Verified date: February 2020
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: Paola Villa, Md PhD
• Phone: +393392318208
• Email: paola.villa[@]policlinicogemelli.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 700
• Est. completion date: October 26, 2021
• Est. primary completion date: December 26, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer Female
• Osteoporosis

Intervention

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

Locations

Country	Name	City	State
Italy	Policlinico Agostino Gemelli	Roma	RM

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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