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Active, not recruitingNCT02839291PRISMUpdated Dec 27, 2024

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

An interventional study of quality of life questionaries and intravenous or oral bone antiresorptive treatments in Tumor With Bone Metastasis, sponsored by Centre Hospitalier Universitaire de Besancon. Active, not recruiting at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-27.

Sponsored by Centre Hospitalier Universitaire de Besancon · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
148
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

03

In context

Neoplasm Metastasis

3,517 studies on the registry are indexed under Neoplasm Metastasis; 885 are open to participants now.

This study's enrollment of 148 is above the median of 54 across 2,767 interventional studies indexed under Neoplasm Metastasis.

Browse Neoplasm Metastasis studies →

Lead sponsor

Centre Hospitalier Universitaire de Besancon is the lead sponsor of 439 studies on the registry; 97 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
148 participants (actual)

Study arms

  • 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

Interventions

  • Otherquality of life questionaries
  • Drugintravenous or oral bone antiresorptive treatments
06

What researchers measure

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

    Time frame: to 6 months

07

Study locations

2 sites
  • Centre Hospitalier Régional Universitaire de Besançon
    Besançon, France
  • Hôpital Nord Franche-Comté
    Montbéliard, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 27, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02839291
Lead sponsor
Centre Hospitalier Universitaire de Besancon
Responsible party
Sponsor
First posted
Jul 20, 2016
Start date
Jun 14, 2016
Primary completion
Feb 5, 2024
Completion
Jan 31, 2025 (estimated)
Last update
Dec 27, 2024
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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