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

May 10, 2022 updated by: Centre Hospitalier Universitaire de Besancon
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

154

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Besançon, France
        • Recruiting
        • Centre Hospitalier Régional Universitaire de Besançon
        • Contact:
        • Principal Investigator:
          • Stéfano KIM, Dr
      • Montbéliard, France
        • Recruiting
        • Hopital Nord Franche-Comte
        • Contact:
        • Principal Investigator:
          • Stéfano KIM, Dr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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)
Other: quality of life questionaries
Drug: intravenous or oral bone antiresorptive treatments

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Besancon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Anticipated)

May 1, 2023

Study Completion (Anticipated)

May 1, 2025

Study Registration Dates

First Submitted

July 18, 2016

First Submitted That Met QC Criteria

July 18, 2016

First Posted (Estimate)

July 20, 2016

Study Record Updates

Last Update Posted (Actual)

May 11, 2022

Last Update Submitted That Met QC Criteria

May 10, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P/2015/279

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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