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

Not Applicable

Active, not recruiting

• Conditions: Tumor With Bone Metastasis
• Interventions: Other: quality of life questionaries; Drug: intravenous or oral bone antiresorptive treatments

• Registration Number: NCT02839291
• Lead Sponsor: Centre Hospitalier Universitaire de Besancon

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2016-06-14
• Study First Submitted: 2016-07-18
• Study First Submitted QC: 2016-07-18
• Study First Posted: 2016-07-20
• Primary Completion: 2024-02-05
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-23
• Last Update Posted: 2024-12-27
• Study Completion: 2025-01-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 148

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
quality of life questionaries	quality of life questionaries	Patients should complete 3 quality of life questionaries (EORTC-QLQ C30 ; EORTC QLQ-BM22 and Euroqol EQ-5D) at many time points : at inclusion, every 3 months and at the end of study visit (2 years after inclusion)
quality of life questionaries	intravenous or oral bone antiresorptive treatments	Patients should complete 3 quality of life questionaries (EORTC-QLQ C30 ; EORTC QLQ-BM22 and Euroqol EQ-5D) at many time points : at inclusion, every 3 months and at the end of study visit (2 years after inclusion)

Primary Outcome Measures

Name	Time	Method
evaluation of 4 targeted dimensions of the EORTC-QLQ-BM22 quality of life questionarie	to 6 months	evaluation of 4 parameters: painful sites characteristics of pain, functional impairment, psychosocial aspect

Trial Locations

Locations (2)

Centre Hospitalier Régional Universitaire de Besançon; 🇫🇷 Besançon, France

Hôpital Nord Franche-Comté; 🇫🇷 Montbéliard, France