Low Back PainPhase 2NCT01330238
The Efficacy of Zoledronic Acid in Modic Changes-related Low Back Pain (LBP)
A Phase 2 study of Low Back Pain, run by University of Oulu at 1 site in Finland.
Trial summary
Modic changes are associated with low back pain (LBP) both in clinical and general population-based samples. Type I changes are regarded as more likely to be painful than type II changes. Several studies suggest that type I changes are inflammatory in nature. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Low Back Pain
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteFinland
- Study dates
- Dec 2008to Mar 2012
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age over 18 years old
- low back pain for more than 3 months
- Modic type I or II change in lumbar magnetic resonance imaging
- Intensity of low back pain at least 6 on 10-cm VAS or Oswestry disability score at least 30%
Who cannot join
- premenopausal female patients with possibility of pregnancy
- patients with calculated creatinine clearance of less than 40 ml/min
- patients with hypocalcemia
- patients with known hypersensitivity to zoledronic acid or other bisphosphonates or ingredients of the infusional product
- patients with red flags symptoms
- patients with nerve root impingement
- patients with willingness for early retirement
Trial locations and contacts
1 site in 1 country.
Finland1 site
Institute of Clinical Sciences, Department of Physical and Rehabilitation Medicine, University of Oulu
Oulu, 90014
About this study
Official title: Phase 2 Study of the Efficacy of Zoledronic Acid in Low Back Pain Related to Vertebral Endplate Signal Changes, the So-called Modic Changes
Modic changes are associated with low back pain (LBP) both in clinical and general population-based samples. Type I changes are regarded as more likely to be painful than type II changes. Several studies suggest that type I changes are inflammatory in nature.
Read the detailed description
So far, no treatment exists for LBP due to Modic changes. Bisphosphonates could be effective in this specific low back disorder through two mechanisms: 1) they could consolidate vertebral bodies thereby improving the tolerance for mechanical load and 2) they could diminish inflammation as observed recently in case of ibandronate in an experimental model.
- Conditions
- Low Back Pain
- Being tested
- Zoledronic acid vs. placebo
- Keywords
- Low back pain, Modic changes, Vertebral endplate signal changes, Efficacy, Zoledronic acid, Bisphosphonates, RCT
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zoledronic acid vs. placeboDrug
Also called Aclasta, Zometa
Single infusion of zoledronic acid or placebo
| Study group | Role | What they receive |
|---|---|---|
| Zoledronic acid | Active comparator | Single infusion of 5 mg zoledronic acid I.V. Receives: Drug: Zoledronic acid vs. placebo |
| Placebo | Placebo comparator | Single infusion of 100 ml isotonic NaCl-solution I.V. Receives: Drug: Zoledronic acid vs. placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Low back pain (VAS)
Measured: 0, 1, 12 months
Secondary outcomes (5)
Health-related quality of life (RAND-36)
Measured: 0, 1, 12 months
Flexibility of the lumbar spine
Modified Schober measure
Measured: 0, 1, 12 months
Sick leaves
Patient-reported
Measured: 0, 12 months
Radiologic phenotype
Change in proportion and size of type I changes
Measured: 0, 12 months
Disability (Oswestry)
Measured: 0, 1, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2011 (estimated)
- Study startDec 2008
- Primary completionMar 2011
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oulu
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Responsible party
- Principal investigator, Katri Koivisto, University of Oulu
- Investigators
- Jaro Karppinen, Prof, Study chair, University of OuluKatri Koivisto, MD, Principal investigator, University of OuluEero Kyllönen, MD, Study director, University Hospital of OuluKaj Sundqvist, MD, Study director, University Hospital of OuluJaakko Niinimäki, MD, Study director, University of OuluOsmo Tervonen, Prof., Study director, University of Oulu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01330238
- Sponsor's protocol ID
- EudraCT 2008-005351-14
- Status last verified
- Jan 2014
- First submitted
- 11 Feb 2011
- Last updated
- 15 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Koivisto K, Jarvinen J, Karppinen J, Haapea M, Paananen M, Kyllonen E, Tervonen O, Niinimaki J. The effect of zoledronic acid on type and volume of Modic changes among patients with low back pain. BMC Musculoskelet Disord. 2017 Jun 23;18(1):274. doi: 10.1186/s12891-017-1632-z.
PubMed 28645291Koivisto K, Kyllonen E, Haapea M, Niinimaki J, Sundqvist K, Pehkonen T, Seitsalo S, Tervonen O, Karppinen J. Efficacy of zoledronic acid for chronic low back pain associated with Modic changes in magnetic resonance imaging. BMC Musculoskelet Disord. 2014 Mar 4;15:64. doi: 10.1186/1471-2474-15-64.
PubMed 24588905
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of the Efficacy of Zoledronic Acid in Low Back Pain Related to Vertebral Endplate Signal Changes, the So-called Modic Changes
- ClinicalTrials.gov ID
- NCT01330238
- Acronym / sponsor ID
- EudraCT 2008-005351-14
- Conditions
- Low Back Pain
- Keywords
- Low back pain, Modic changes, Vertebral endplate signal changes, Efficacy, Zoledronic acid, Bisphosphonates, RCT
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of OuluUniversity, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Study start
- Dec 2008
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 6 Apr 2011 (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.
Modic changes are associated with low back pain (LBP) both in clinical and general population-based samples. Type I changes are regarded as more likely to be painful than type II changes. Several studies suggest that type I changes are inflammatory in nature.
Detailed description
So far, no treatment exists for LBP due to Modic changes. Bisphosphonates could be effective in this specific low back disorder through two mechanisms: 1) they could consolidate vertebral bodies thereby improving the tolerance for mechanical load and 2) they could diminish inflammation as observed recently in case of ibandronate in an experimental model.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zoledronic acid | Active comparator | Drug: Zoledronic acid vs. placeboSingle infusion of 5 mg zoledronic acid I.V. |
| Placebo | Placebo comparator | Drug: Zoledronic acid vs. placeboSingle infusion of 100 ml isotonic NaCl-solution I.V. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age over 18 years old
- low back pain for more than 3 months
- Modic type I or II change in lumbar magnetic resonance imaging
- Intensity of low back pain at least 6 on 10-cm VAS or Oswestry disability score at least 30%
Key exclusion criteria (7 listed)
- premenopausal female patients with possibility of pregnancy
- patients with calculated creatinine clearance of less than 40 ml/min
- patients with hypocalcemia
- patients with known hypersensitivity to zoledronic acid or other bisphosphonates or ingredients of the infusional product
- patients with red flags symptoms
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 |
|---|---|---|
| Zoledronic acid vs. placeboAlso: Aclasta, ZometaSingle infusion of zoledronic acid or placebo | Drug | Placebo, Zoledronic acid |
Primary outcome
Low back pain (VAS)
Time frame: 0, 1, 12 months
5 secondary outcomes
Health-related quality of life (RAND-36)
Time frame: 0, 1, 12 months
Flexibility of the lumbar spine
Time frame: 0, 1, 12 months
Sick leaves
Time frame: 0, 12 months
Radiologic phenotype
Time frame: 0, 12 months
Disability (Oswestry)
Time frame: 0, 1, 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2014.
- Derived from this study: PubMed 28645291Koivisto K, Jarvinen J, Karppinen J, Haapea M, Paananen M, Kyllonen E, Tervonen O, Niinimaki J. The effect of zoledronic acid on type and volume of Modic changes among patients with low back pain. BMC Musculoskelet Disord. 2017 Jun 23;18(1):274. doi: 10.1186/s12891-017-1632-z.
- Derived from this study: PubMed 24588905Koivisto K, Kyllonen E, Haapea M, Niinimaki J, Sundqvist K, Pehkonen T, Seitsalo S, Tervonen O, Karppinen J. Efficacy of zoledronic acid for chronic low back pain associated with Modic changes in magnetic resonance imaging. BMC Musculoskelet Disord. 2014 Mar 4;15:64. doi: 10.1186/1471-2474-15-64.
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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.
Jaro Karppinen, Prof study chair
University of Oulu
Katri Koivisto, MD principal investigator
University of Oulu
Eero Kyllönen, MD study director
University Hospital of Oulu
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 of Low Back Pain, run by University of Oulu at 1 site in Finland.
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 4 inclusion and 7 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: finished, as of the sponsor's last update on 15 Jan 2014. 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 Finland. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Low back pain (VAS) (time frame: 0, 1, 12 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 NCT01330238, which also lists 2 linked publications.
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 15 Jan 2014.