Evaluation of Medical Practice in the Management of Bone Metastases After Injectable Bone Antiresorptive Treatment, and Its Influence on Quality of Life

Tumor With Bone Metastasis Clinical Trial

— PRISM  

Official title:

Evaluation of Medical Practice in the Management of Bone Metastases After Injectable Bone Antiresorptive Treatment, and Its Influence on Quality of Life

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02839291
• Other study ID #: P/2015/279
• Status: Recruiting
• Phase: N/A
• Start date: May 2016
• Est. completion date: May 2025

Study information

• Verified date: May 2022
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: Stefano KIM, Dr
• Email: stefanokim[@]me.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the current medical practice and its influence on health-related quality of life, in patients who are treated with injectable bone antiresorptive drugs (biphosphonates or denosumab) for at least one year.

Description:

This protocol will evaluate the pursuit of injectable bone antiresorptive treatments or their switch to oral biphosphonates, or treatment stop, in the contexte of medical practice.

The primary end-point is the health-related quality of life (QoL). Secondary endpoints are safety, overall survial, the impact of toxicities of the treatment on QoL, and the description of supportive care.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 154
• Est. completion date: May 2025
• Est. primary completion date: May 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient with histologically proven tumor with bone metastasis, single or multiple (with or without metastasis extra-osseous)

• Patients treated with injectable bone antiresorptive therapy for 12 months or more

• Signed written informed consent

Exclusion Criteria:

• patient with any medical or psychiatric condition or disease which would make the patient inappropriate to complete quality of life questionaries

• patient under guardianship, curator or under the protection of justice, pregnant or breast-feeding women

Related Conditions & MeSH terms

• Bone Marrow Diseases
• Bone Neoplasms
• Neoplasm Metastasis
• Tumor With Bone Metastasis

Intervention

Other:
• quality of life questionaries

Drug:
• intravenous or oral bone antiresorptive treatments

Locations

Country	Name	City	State
France	Centre Hospitalier Régional Universitaire de Besançon	Besançon
France	Hôpital Nord Franche-Comté	Montbéliard

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	evaluation of 4 targeted dimensions of the EORTC-QLQ-BM22 quality of life questionarie	evaluation of 4 parameters: painful sites characteristics of pain, functional impairment, psychosocial aspect	to 6 months