Active, Not Recruiting
NCT Number: NCT02839291
Evaluation of Medical Practice in the Management of Bone Metastases After Injectable Bone Antiresorptive Treatment, and Its Influence on Quality of Life
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.
Active, Not Recruiting
This study is active but is not currently recruiting participants.
Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Centre Hospitalier Régional Universitaire de Besançon, Besançon, France
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About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
intravenous or oral bone antiresorptive treatments
DrugPrimary outcomes
-
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
Sponsors and collaborators
Lead sponsor
Centre Hospitalier Universitaire de Besancon
Other
Registry information
Acronym: PRISM
Important dates
- Study start
- 2016
- Primary completion
- 2024
- Study completion
- 2025
- First posted
- Jul 20, 2016
- Registry last updated
- Dec 27, 2024
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.