NCT02839291

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
148

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 14, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 18, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 20, 2016

Completed
7.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 5, 2024

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2025

Completed
Last Updated

December 27, 2024

Status Verified

December 1, 2024

Enrollment Period

7.6 years

First QC Date

July 18, 2016

Last Update Submit

December 23, 2024

Conditions

Tumor With Bone Metastasis

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

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)

Other: quality of life questionariesDrug: intravenous or oral bone antiresorptive treatments

Interventions

quality of life questionariesOTHER
quality of life questionaries
intravenous or oral bone antiresorptive treatmentsDRUG
quality of life questionaries

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centre Hospitalier Régional Universitaire de Besançon

Besançon, France

Location

Hôpital Nord Franche-Comté

Montbéliard, France

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2016

First Posted

July 20, 2016

Study Start

June 14, 2016

Primary Completion

February 5, 2024

Study Completion

January 31, 2025

Last Updated

December 27, 2024

Record last verified: 2024-12

Locations

FR(2)