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

NCT ID: NCT02839291

Last Updated: 2024-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

148 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-14

Study Completion Date

2025-01-31

Brief Summary

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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

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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.

Conditions

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Tumor With Bone Metastasis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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)

Group Type EXPERIMENTAL

quality of life questionaries

Intervention Type OTHER

intravenous or oral bone antiresorptive treatments

Intervention Type DRUG

Interventions

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quality of life questionaries

Intervention Type OTHER

intravenous or oral bone antiresorptive treatments

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Besancon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Centre Hospitalier Régional Universitaire de Besançon

Besançon, , France

Site Status

Hôpital Nord Franche-Comté

Montbéliard, , France

Site Status

Countries

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France

Other Identifiers

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P/2015/279

Identifier Type: -

Identifier Source: org_study_id