Tumor With Bone MetastasisPRISMNCT02839291
Evaluation of Medical Practice in the Management of Bone Metastases After Injectable Bone Antiresorptive Treatment, and Its Influence on Quality of Life
A study testing quality of life questionaries and intravenous or oral bone antiresorptive treatments in people with Tumor With Bone Metastasis, run by Centre Hospitalier Universitaire de Besancon at 2 sites in France.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tumor With Bone Metastasis
- What is being tested?
- quality of life questionaries and intravenous or oral bone antiresorptive treatments
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 2 sitesFrance
- Study dates
- 14 Jun 2016to 31 Jan 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
France2 sites
Centre Hospitalier Régional Universitaire de Besançon
Besançon
Hôpital Nord Franche-Comté
Montbéliard
About this study
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.
- Conditions
- Tumor With Bone Metastasis
- Being tested
- quality of life questionaries, intravenous or oral bone antiresorptive treatments
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
quality of life questionariesOther
intravenous or oral bone antiresorptive treatmentsDrug
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Other: quality of life questionaries; Drug: intravenous or oral bone antiresorptive treatments |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2016 (estimated)
- Study start14 Jun 2016
- Primary completion5 Feb 2024
- Study completion31 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tumor With Bone MetastasisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02839291
- Sponsor's protocol ID
- P/2015/279
- Acronym
- PRISM
- Status last verified
- Dec 2024
- First submitted
- 18 Jul 2016
- Last updated
- 27 Dec 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Medical Practice in the Management of Bone Metastases After Injectable Bone Antiresorptive Treatment, and Its Influence on Quality of Life
- ClinicalTrials.gov ID
- NCT02839291
- Acronym / sponsor ID
- PRISM / P/2015/279
- Conditions
- Tumor With Bone Metastasis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 14 Jun 2016 (actual)
- Primary completion
- 5 Feb 2024 (actual)
- Study completion
- 31 Jan 2025 (estimated)
- First posted
- 20 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| quality of life questionaries | Experimental | Other: quality of life questionaries, Drug: intravenous or oral bone antiresorptive treatmentsPatients 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| quality of life questionaries | Other | quality of life questionaries |
| intravenous or oral bone antiresorptive treatments | Drug | quality of life questionaries |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing quality of life questionaries and intravenous or oral bone antiresorptive treatments in people with Tumor With Bone Metastasis, run by Centre Hospitalier Universitaire de Besancon at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evaluation of 4 targeted dimensions of the EORTC-QLQ-BM22 quality of life questionarie (time frame: to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2024.