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

  • STATUS
    Recruiting
  • End date
    May 27, 2025
  • participants needed
    154
  • sponsor
    Centre Hospitalier Universitaire de Besancon
Updated on 27 May 2022

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.

Details
Condition Tumor With Bone Metastasis
Treatment quality of life questionaries, intravenous or oral bone antiresorptive treatments
Clinical Study IdentifierNCT02839291
SponsorCentre Hospitalier Universitaire de Besancon
Last Modified on27 May 2022

Eligibility

Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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