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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| quality of life questionaries | Experimental | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| quality of life questionaries | Other |
| ||
| intravenous or oral bone antiresorptive treatments |
| Measure | Description | Time Frame |
|---|---|---|
| evaluation of 4 targeted dimensions of the EORTC-QLQ-BM22 quality of life questionarie | evaluation of 4 parameters: painful sites characteristics of pain, functional impairment, psychosocial aspect | to 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Régional Universitaire de Besançon | Besançon | France | ||||
| Hôpital Nord Franche-Comté |
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| Drug |
|
| Montbéliard |
| France |