Intervertebral Disc DegenerationPhase 2NCT01799616
Efficiency and Safety Study of Pamidronate in Inflammatory Back Pain Due to Degenerative Disk Disease
A Phase 2 study testing Pamidronate in people with Intervertebral Disc Degeneration and Modic I Discopathy, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
The purpose of this study is to determine whether pamidronate is effective and well-tolerated in the treatment of painful degenerative disk disease, also known as Modic type 1 changes Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Intervertebral Disc Degeneration, Modic I Discopathy, Back Pain
- What is being tested?
- Pamidronate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2013to Mar 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- - Age from 18 to 60 years old
- Low back pain
- Daily pain since at least 3 months
- VAS for pain > 40/100 during the last 48 hours
- Inefficiency, intolerance, or contraindication to NSAIDS
- Inefficiency of a rigid or half-rigid back brace
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- Modic 1 discopathy (diagnosed on MRI and confirmed by trained radiologist)
- Dental check-up within the last 6 months
- Signed informed consent
Who cannot join
- - Static disorders of the spine
- Contraindication to pamidronate (hypocalcemia, severe kidney failure, or allergy)
- Underage patients, patients under the protection of the law
- Previous treatment with bisphosphonates
- Pregnancy
- Local or general infection
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- Previous discal surgery
- Systemic corticosteroid therapy in the last month
- Epidural or facet joint corticosteroid injection in the last month
- History of septic spondylodiscitis
- Ankylosing spondylitis
- Low back pain associated with radiculalgia
- Active psychiatric disorder
- Inability to read or understand French
- Body temperature above 38°C (fever) or Erythrocyte Sedimentation Rate above 20mm/hour
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Clermont-Ferrand
Clermont-Ferrand, 63003
Patrick LACARIN, 04 73 75 11 95, placarin@chu-clermontferrand.fr
About this study
The purpose of this study is to determine whether pamidronate is effective and well-tolerated in the treatment of painful degenerative disk disease, also known as Modic type 1 changes
Read the detailed description
Erosive degenerative disk disease, also known as Modic type 1 changes, is usually characterized by low back pain, with an inflammatory pain pattern, as seen in spondylarthropathies. Intravenous pamidronate has proven effective in patients with ankylosing spondylitis, and in painful bone diseases in general. We therefore hypothesized that pamidronate would be effective in treating back pain associated with Modic type 1 changes.
This study aimed to determine pamidronate's efficiency in reducing pain, with the primary outcome being a between-group difference of 30 points on a 100mm VAS at 3 months. Secondary outcomes are the improvement in functional status and the drug's tolerance. Primary and secondary outcome criteria will be assessed at each visit (inclusion, at 6 weeks, 3 months, and 6 months). If the primary goal is not attained, a rigid or semi-rigid back brace will be proposed to the patient, regardless of the treatment group.
In total, 48 patients will need to be recruited. These patients will be randomly assigned to one of the two groups, with each group comprising 24 patients: one group will be given pamidronate and the other placebo. Pamidronate will be administered at a dose of 90mg per day, 2 days in a row, and every patient, regardless of the treatment group, will be given paracetamol, in order to maintain blinding by preventing drug-induced fever.
- Conditions
- Intervertebral Disc Degeneration, Modic I Discopathy, Back Pain, Low Back Pain, Magnetic Resonance Imaging (MRI)
- Being tested
- Pamidronate, Placebo
- Keywords
- MODIC changes, Chronic low back pain, Pamidronate, Magnetic resonance imaging, Vertebrae, Intervertebral disc
- Medical subject headings
- Intervertebral Disc Degeneration, Back Pain, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PamidronateDrug
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| Pamidronate | Experimental | In total, 48 patients will need to be recruited. These patients will be randomly assigned to one of the two groups, with each group comprising 24 patients: one group will be given pamidronate and the other placebo Receives: Drug: Pamidronate |
| Placebo | Other | In total, 48 patients will need to be recruited. These patients will be randomly assigned to one of the two groups, with each group comprising 24 patients: one group will be given pamidronate and the other placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
back pain assessed on a100mm VAS
Measured: at 3 months
Secondary outcomes (5)
- Functional status using EIFEL, Dallas, FABQ, MacTar, and MCII/PASS questionnaires
Measured: at 6 weeks, 3 months, and 6 months
Back stiffness assessed by Schober's test and finger-to-floor distance
Measured: at 6 weeks, 3 months, and 6 months
Inflammatory pain pattern
Inflammatory pain pattern: number of nightly awakenings, as well as duration and intensity of morning stiffness on a 100mm VAS
Measured: at 6 weeks, 3 months, and 6 months
assess the efficacy of a rigid back brace in treating back pain
In case of failure to reduce the pain with pamidronate at 3 months: assess the efficacy of a rigid back brace in treating back pain
Measured: at 6 weeks, 3 months, and 6 months
Tolerance based on the number and types of side-effects
Measured: at 6 weeks, 3 months, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2013 (estimated)
- Study startJan 2013
- Primary completionJan 2015 (estimated)
- Study completionMar 2015 (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 Intervertebral Disc DegenerationStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- INSERM CIC 501
- Responsible party
- Sponsor
- Investigators
- Martin SOUBRIER, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01799616
- Sponsor's protocol ID
- CHU-0148
- Other IDs
- 2012-003569-16
- Status last verified
- Feb 2013
- First submitted
- 21 Feb 2013
- Last updated
- 27 Feb 2013
- Results posted
- No
Publications
Cecchetti S, Pereira B, Roche A, Deschaumes C, Abdi D, Coudeyre E, Dubost JJ, Mathieu S, Malochet-Guinamand S, Tournadre A, Couderc M, Vayssade M, Daron C, Soubrier M. Efficacy and safety of pamidronate in Modic type 1 changes: study protocol for a prospective randomized controlled clinical trial. Trials. 2014 Apr 9;15:117. doi: 10.1186/1745-6215-15-117.
PubMed 24716739
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficiency and Safety Study of Pamidronate in Inflammatory Back Pain Due to Degenerative Disk Disease
- ClinicalTrials.gov ID
- NCT01799616
- Acronym / sponsor ID
- CHU-0148
- Conditions
- Intervertebral Disc Degeneration, Modic I Discopathy, Back Pain, Low Back Pain, Magnetic Resonance Imaging (MRI)
- Keywords
- MODIC changes, Chronic low back pain, Pamidronate, Magnetic resonance imaging, Vertebrae, Intervertebral disc
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- INSERM CIC 501
- Study start
- Jan 2013
- Primary completion
- Jan 2015 (estimated)
- Study completion
- Mar 2015 (estimated)
- First posted
- 27 Feb 2013 (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.
The purpose of this study is to determine whether pamidronate is effective and well-tolerated in the treatment of painful degenerative disk disease, also known as Modic type 1 changes
Detailed description
Erosive degenerative disk disease, also known as Modic type 1 changes, is usually characterized by low back pain, with an inflammatory pain pattern, as seen in spondylarthropathies. Intravenous pamidronate has proven effective in patients with ankylosing spondylitis, and in painful bone diseases in general. We therefore hypothesized that pamidronate would be effective in treating back pain associated with Modic type 1 changes.
This study aimed to determine pamidronate's efficiency in reducing pain, with the primary outcome being a between-group difference of 30 points on a 100mm VAS at 3 months. Secondary outcomes are the improvement in functional status and the drug's tolerance. Primary and secondary outcome criteria will be assessed at each visit (inclusion, at 6 weeks, 3 months, and 6 months). If the primary goal is not attained, a rigid or semi-rigid back brace will be proposed to the patient, regardless of the treatment group.
In total, 48 patients will need to be recruited. These patients will be randomly assigned to one of the two groups, with each group comprising 24 patients: one group will be given pamidronate and the other placebo. Pamidronate will be administered at a dose of 90mg per day, 2 days in a row, and every patient, regardless of the treatment group, will be given paracetamol, in order to maintain blinding by preventing drug-induced fever.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pamidronate | Experimental | Drug: PamidronateIn total, 48 patients will need to be recruited. These patients will be randomly assigned to one of the two groups, with each group comprising 24 patients: one group will be given pamidronate and the other placebo |
| Placebo | Other | Other: PlaceboIn total, 48 patients will need to be recruited. These patients will be randomly assigned to one of the two groups, with each group comprising 24 patients: one group will be given pamidronate and the other placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- - Age from 18 to 60 years old
- Low back pain
- Daily pain since at least 3 months
- VAS for pain > 40/100 during the last 48 hours
- Inefficiency, intolerance, or contraindication to NSAIDS
Key exclusion criteria (15 listed)
- - Static disorders of the spine
- Contraindication to pamidronate (hypocalcemia, severe kidney failure, or allergy)
- Underage patients, patients under the protection of the law
- Previous treatment with bisphosphonates
- Pregnancy
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 |
|---|---|---|
| Pamidronate | Drug | Pamidronate |
| Placebo | Other | Placebo |
Primary outcome
back pain assessed on a100mm VAS
Time frame: at 3 months
5 secondary outcomes
- Functional status using EIFEL, Dallas, FABQ, MacTar, and MCII/PASS questionnaires
Time frame: at 6 weeks, 3 months, and 6 months
Back stiffness assessed by Schober's test and finger-to-floor distance
Time frame: at 6 weeks, 3 months, and 6 months
Inflammatory pain pattern
Time frame: at 6 weeks, 3 months, and 6 months
assess the efficacy of a rigid back brace in treating back pain
Time frame: at 6 weeks, 3 months, and 6 months
Tolerance based on the number and types of side-effects
Time frame: at 6 weeks, 3 months, and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2013.
- Derived from this study: PubMed 24716739Cecchetti S, Pereira B, Roche A, Deschaumes C, Abdi D, Coudeyre E, Dubost JJ, Mathieu S, Malochet-Guinamand S, Tournadre A, Couderc M, Vayssade M, Daron C, Soubrier M. Efficacy and safety of pamidronate in Modic type 1 changes: study protocol for a prospective randomized controlled clinical trial. Trials. 2014 Apr 9;15:117. doi: 10.1186/1745-6215-15-117.
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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.
Martin SOUBRIER principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pamidronate in people with Intervertebral Disc Degeneration and Modic I Discopathy, run by University Hospital, Clermont-Ferrand at 1 site 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 9 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 27 Feb 2013. 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 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrick LACARIN (04 73 75 11 95, placarin@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
back pain assessed on a100mm VAS (time frame: at 3 months). 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 NCT01799616, 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 27 Feb 2013.