Vertebral FractureNCT04533217
Examination of Vertebroplasty in Addition to Regular Treatment of Patients With Multiple Myeloma.
A study testing Vertebroplasty in people with Vertebral Fracture and Multiple Myeloma, run by Spine Centre of Southern Denmark at 1 site in Denmark.
Trial summary
Patients with newly diagnosed or known multiple myeloma with newly diagnosed vertebral lesion(s) will be invited to participate in a cross-sectoral randomized controlled trial. The trial will compare two groups of patients which either receive regular medical treatment of their vertebral lesion(s) or vertebroplasty in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vertebral Fracture, Multiple Myeloma
- What is being tested?
- Vertebroplasty
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteDenmark
- Study dates
- 29 Mar 2021to 31 Jul 2026
- 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
- known multiple myeloma
- verified lesion(s) between Th6-L5
- 4 or less fractures
- relevant pain in 3 months or less
- vertebroplasty can be performed in one procedure
- VAS 5 or more
Who cannot join
- presence of neurologic deficit
- psychological or psychiatric disorder hat is expected to interfere with compliance
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Center for Spine Surgery and Research
Middelfart, Region Syddanmark, 5500
Line Wickstrøm, MD, +4524411994, line.adsboll.wickstrom@rsyd.dk
About this study
Official title: Palliative Treatment of Patients With Multiple Myeloma and Painful Vertebral Lesions. A Cross-sectoral Randomized Controlled Trial of Vertebroplasty in Addition to Regular Medical Treatment.
Patients with newly diagnosed or known multiple myeloma with newly diagnosed vertebral lesion(s) will be invited to participate in a cross-sectoral randomized controlled trial. The trial will compare two groups of patients which either receive regular medical treatment of their vertebral lesion(s) or vertebroplasty in addition to regular medical treatment. Our goal is to investigate the effectiveness of vertebroplasty and determine the role of surgical treatment in the overall treatment of patients with multiple myeloma and vertebral lesion(s).
Read the detailed description
Patients identified by the attending consultant as eligible are invited to participate. Patients who express an interest in participating will be given written and oral information on the purpose, nature and implications of study-participation.
Possible candidates will be identified at the departments of Hematology where the patients are treated for their disease. All Danish departments of Hematology will be invited to participate.
The hematologist will inform the patient of the protocol and decide if they fulfil the inclusion and exclusion criteria. If the patient wishes to participate the hematologist will fill out screening forms regarding disease stage, lines of treatment, current disease status, bisphosphonate status, and pain relief treatment. The hematologist will refer the patient to their collaborating surgical department. The surgical department will decide if the patient has contraindications for surgery and inform the patient of the risk of the procedure.
If the patient decides to participate, he or she will fill out forms regarding ODI, VAS pain score, QoL.
Before randomization, the patients will be divided into two groups, stratifying between patients with known multiple myeloma with new diagnosed spine fracture and relevant pain ≤ 3 months prior to inclusion and patients with newly diagnosed multiple myeloma with new spine fracture.
Furthermore, to ensure balanced control and intervention groups the included patients at randomization will be stratified according to 1) panned PVP of 1 vs 2-4 levels, and 2) former vertebral fractures that are not planned treated with PVP.
The patients will be randomized to either PVP treatment or conservative treatment by drawing. It is therefore not possible for patients to choose between the treatments.
Patients randomized to vertebroplasty will be referred to a facility performing vertebroplasty. Patients randomized to non-vertebroplasty will receive the departments' usual care with the option to change treatment arm after 4 weeks.
The randomization will be performed by the diagnosing clinician, but orchestrated by one individual central to the clinics. The clinics will receive sealed envelopes containing the choice of randomization equally divided between PVP and conservative treatment. When all sealed envelopes have been used for randomization, the clinics will receive new envelopes.
It will not be possible to randomize more than one patient at a time. All patients will be contacted by a research nurse on a weekly basis the first 12 weeks after enrolment and after 3 and 12 months.
All patients randomized to vertebroplasty will undergo standard operative treatment involving a standard scheduled outpatient clinical control with the surgeon 12-weeks post-operative including long-standing radiographs of the spine.
- Conditions
- Vertebral Fracture, Multiple Myeloma
- Being tested
- Vertebroplasty
- Medical subject headings
- Spinal Fractures, Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VertebroplastyProcedure or surgery
Injection of cement into vertebral lesion(s)
| Study group | Role | What they receive |
|---|---|---|
| Vertebroplasty | Active comparator | Patients treated with vertebroplasty in addition to regular medical treatment. Receives: Procedure: Vertebroplasty |
| Regular treatment | No intervention | Patients treated with regular medical treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in back-specific disability
Oswestry Disability Index v2.1 (ODI): Each section is scored on a 0-5 scale, with 5 representing the highest disability.
Measured: 4 weeks post-initiation of treatment
Secondary outcomes (5)
Improvement in back-specific disability
ODI
Measured: Up to 12 months post-initiation of treatment
Back and leg pain
Visual Analogue Scale (VAS): 0-100 scale, with 100 representing the largest amount of pain
Measured: Up to 12 months post-initiation of treatment
Movement, personal care, usual activities, pain/discomfort, depression/anxiety
Self-reported questionnaire on quality of life using:
- European Quality of Life - 5 Dimension (EQ-5D): 0-2 scale, with 2 representing the highest disability
EQ-5D contains questions on topics contributing to the overall feeling of quality of life:
- movement
- personal care
- usual activities (ex. occupation, family activities)
- pain/discomfort
- depression/anxiety.
Measured: Up to 12 months post-initiation of treatment
Long-term stability of treated vertebra(e)
X-rays will be used to analyze long-term stability.
Measured: 12 months post-initiation of treatment
General health services
General questionnaires on wether or not and to what extend the patients have been using general health services.
Measured: Up to 12 moths post-initiation of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2020
- Study start29 Mar 2021
- Primary completion31 Jul 2025 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vertebral FractureStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Spine Centre of Southern Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mikkel Andersen, Professor, Principal investigator, Centre of Spine Surgery and Research, Middelfart Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04533217
- Sponsor's protocol ID
- S-20200075
- Status last verified
- Nov 2024
- First submitted
- 9 Jun 2020
- Last updated
- 3 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data of long-term value will be stored, e.g. for use in future studies on shorter-term or long-term follow-up or reuse. Metadata and anonymized data will be available for other researchers if possible due to confidentiality and GDPR.
Publications
Wickstroem LA, Carreon L, Lund T, Abildgaard N, Lorenzen MD, Andersen MO. Vertebroplasty in patients with multiple myeloma with vertebral compression fractures: protocol for a single-blind randomised controlled trial. BMJ Open. 2021 Sep 6;11(9):e045854. doi: 10.1136/bmjopen-2020-045854.
PubMed 34489267
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Palliative Treatment of Patients With Multiple Myeloma and Painful Vertebral Lesions. A Cross-sectoral Randomized Controlled Trial of Vertebroplasty in Addition to Regular Medical Treatment.
- ClinicalTrials.gov ID
- NCT04533217
- Acronym / sponsor ID
- S-20200075
- Conditions
- Vertebral Fracture, Multiple Myeloma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Spine Centre of Southern DenmarkUniversity, hospital or other
- Study start
- 29 Mar 2021 (actual)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 31 Aug 2020 (actual)
- 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.
Patients with newly diagnosed or known multiple myeloma with newly diagnosed vertebral lesion(s) will be invited to participate in a cross-sectoral randomized controlled trial. The trial will compare two groups of patients which either receive regular medical treatment of their vertebral lesion(s) or vertebroplasty in addition to regular medical treatment. Our goal is to investigate the effectiveness of vertebroplasty and determine the role of surgical treatment in the overall treatment of patients with multiple myeloma and vertebral lesion(s).
Detailed description
Patients identified by the attending consultant as eligible are invited to participate. Patients who express an interest in participating will be given written and oral information on the purpose, nature and implications of study-participation.
Possible candidates will be identified at the departments of Hematology where the patients are treated for their disease. All Danish departments of Hematology will be invited to participate.
The hematologist will inform the patient of the protocol and decide if they fulfil the inclusion and exclusion criteria. If the patient wishes to participate the hematologist will fill out screening forms regarding disease stage, lines of treatment, current disease status, bisphosphonate status, and pain relief treatment. The hematologist will refer the patient to their collaborating surgical department. The surgical department will decide if the patient has contraindications for surgery and inform the patient of the risk of the procedure.
If the patient decides to participate, he or she will fill out forms regarding ODI, VAS pain score, QoL.
Before randomization, the patients will be divided into two groups, stratifying between patients with known multiple myeloma with new diagnosed spine fracture and relevant pain ≤ 3 months prior to inclusion and patients with newly diagnosed multiple myeloma with new spine fracture.
Furthermore, to ensure balanced control and intervention groups the included patients at randomization will be stratified according to 1) panned PVP of 1 vs 2-4 levels, and 2) former vertebral fractures that are not planned treated with PVP.
The patients will be randomized to either PVP treatment or conservative treatment by drawing. It is therefore not possible for patients to choose between the treatments.
Patients randomized to vertebroplasty will be referred to a facility performing vertebroplasty. Patients randomized to non-vertebroplasty will receive the departments' usual care with the option to change treatment arm after 4 weeks.
The randomization will be performed by the diagnosing clinician, but orchestrated by one individual central to the clinics. The clinics will receive sealed envelopes containing the choice of randomization equally divided between PVP and conservative treatment. When all sealed envelopes have been used for randomization, the clinics will receive new envelopes.
It will not be possible to randomize more than one patient at a time. All patients will be contacted by a research nurse on a weekly basis the first 12 weeks after enrolment and after 3 and 12 months.
All patients randomized to vertebroplasty will undergo standard operative treatment involving a standard scheduled outpatient clinical control with the surgeon 12-weeks post-operative including long-standing radiographs of the spine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vertebroplasty | Active comparator | Procedure: VertebroplastyPatients treated with vertebroplasty in addition to regular medical treatment. |
| Regular treatment | No intervention | –Patients treated with regular medical treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- known multiple myeloma
- verified lesion(s) between Th6-L5
- 4 or less fractures
- relevant pain in 3 months or less
- vertebroplasty can be performed in one procedure
Key exclusion criteria (2 listed)
- presence of neurologic deficit
- psychological or psychiatric disorder hat is expected to interfere with compliance
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 |
|---|---|---|
| VertebroplastyInjection of cement into vertebral lesion(s) | Procedure or surgery | Vertebroplasty |
Primary outcome
Improvement in back-specific disability
Time frame: 4 weeks post-initiation of treatment
Oswestry Disability Index v2.1 (ODI): Each section is scored on a 0-5 scale, with 5 representing the highest disability.
5 secondary outcomes
Improvement in back-specific disability
Time frame: Up to 12 months post-initiation of treatment
Back and leg pain
Time frame: Up to 12 months post-initiation of treatment
Movement, personal care, usual activities, pain/discomfort, depression/anxiety
Time frame: Up to 12 months post-initiation of treatment
Long-term stability of treated vertebra(e)
Time frame: 12 months post-initiation of treatment
General health services
Time frame: Up to 12 moths post-initiation of treatment
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 3 Dec 2024.
- Derived from this study: PubMed 34489267Wickstroem LA, Carreon L, Lund T, Abildgaard N, Lorenzen MD, Andersen MO. Vertebroplasty in patients with multiple myeloma with vertebral compression fractures: protocol for a single-blind randomised controlled trial. BMJ Open. 2021 Sep 6;11(9):e045854. doi: 10.1136/bmjopen-2020-045854.
- Individual participant dataSharing planned: Yes. All data of long-term value will be stored, e.g. for use in future studies on shorter-term or long-term follow-up or reuse. Metadata and anonymized data will be available for other researchers if possible due to confidentiality and GDPR.
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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.
Mikkel Andersen, Professor principal investigator
Centre of Spine Surgery and Research, Middelfart Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vertebroplasty in people with Vertebral Fracture and Multiple Myeloma, run by Spine Centre of Southern Denmark at 1 site in Denmark.
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 6 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: looking for participants now, as of the sponsor's last update on 3 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 1 site in Denmark. 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?
Contact Line Wickstroem, MD (+4524411994, line.adsboll.wickstrom@rsyd.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in back-specific disability (time frame: 4 weeks post-initiation of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04533217, which also lists 1 linked publication.
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 3 Dec 2024.