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Study on Zoledronic Acid for Patients with Chronic Low Back Pain with Modic Changes

Fast replyRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a medication called Zoledronic Acid on individuals experiencing chronic low back pain with specific changes in the spine known as Modic changes. The treatment being tested is called Aclasta, which is a solution given through an infusion into the vein. The study will compare the effects of Zoledronic Acid to a placebo, which is a treatment that looks like the real medication but does not contain the active substance.

The purpose of the study is to determine if Zoledronic Acid can effectively reduce disability related to back pain. Participants in the study will receive two infusions of Zoledronic Acid over a period of time. The study will monitor changes in the participants' ability to perform daily activities and their overall pain levels over the course of one year. The main focus will be on how the treatment affects the participants' scores on a questionnaire called the Oswestry Disability Index, which measures the impact of back pain on their daily life.

Throughout the study, researchers will also look at other factors, such as changes in pain intensity, overall health status, and any additional treatments participants may use. The study aims to provide valuable information on whether Zoledronic Acid can be a beneficial treatment for those suffering from chronic low back pain with Modic changes.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes evaluating the presence of chronic low back pain with specific characteristics, such as pain duration and intensity, and Modic changes in the spine.
Step 2
First infusion
The first treatment involves an intravenous infusion of zoledronic acid at a dose of 5 mg. This is administered as a solution for infusion, specifically designed to be delivered directly into the bloodstream.
Step 3
Monitoring period
After the first infusion, a monitoring period follows to observe any immediate effects or reactions. This period ensures the safety and well-being of the participant.
Step 4
Second infusion
A second infusion of zoledronic acid at the same dosage of 5 mg is administered. This occurs after a specified interval, ensuring the treatment regimen is followed as planned.
Step 5
Follow-up assessments
Regular follow-up assessments are conducted to evaluate changes in back-specific disability and pain intensity. These assessments use tools like the Oswestry Disability Index (ODI) and Numerical Rating Scale (NRS) to measure outcomes.
Step 6
Final evaluation
At the end of the trial period, a final evaluation is performed to assess the overall impact of the treatment. This includes a comprehensive review of disability scores, pain levels, and any other relevant health indicators.

Who can join the trial?

7 criteria

You must have **low back pain** for more than 50% of the days over the past 6 months. This pain should be located below the 12th rib and above the buttocks.
Your **Oswestry Disability Index (ODI)** score should be 30 or higher. The ODI is a questionnaire that measures how much your back pain affects your daily life.
Your **Numerical Rating Scale (NRS)** pain intensity score should be 5 or higher. This score is the average of three ratings: your current back pain, the worst back pain in the last 2 weeks, and your usual back pain in the last 2 weeks.
You must have **Modic changes** of type 1 in your spine. These are specific changes seen in the bones of your spine on an MRI scan.
The height of these Modic changes should be at least 10% of the height of the vertebral body, and the diameter should be more than 5 mm.
You must be between 18 and 65 years old.
Both men and women can participate in the study.

Who cannot join the trial?

4 criteria

Patients who are not experiencing chronic low back pain with Modic changes cannot participate. Chronic low back pain means having back pain for a long time, and Modic changes are specific changes in the spine seen on an MRI scan.
Patients who are not within the specified age range for the study cannot participate. The age range is typically defined by the study, but it is not specified here.
Patients who are part of a vulnerable population, such as those who cannot give consent or are in a dependent situation, cannot participate.
Patients who do not meet other specific health criteria set by the study cannot participate. These criteria are not detailed here.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Helse Bergen HF
Bergen, Norway
Verified
Oslo Universitetssykehus HF
Oslo, Norway
Responsive
Sykehuset Oestfold HF Kalnes
Graalum, Norway

Trial locations

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Investigated drugs

Zoledronic Acid is a medication used in this trial to see if it can help reduce back pain and improve function in people with chronic low back pain. It is given through an infusion, which means it is delivered directly into the bloodstream. The trial aims to find out if this medication is more effective than a placebo in reducing disability related to back pain.

What is already known about the treatment

Zoledronic Acid – Zoledronic acid is administered through an intravenous infusion. It is currently being studied in clinical trials for its effectiveness in treating chronic low back pain associated with Modic changes. The main therapeutic indication is to reduce back-specific disability in patients with this condition. At the molecular level, zoledronic acid works by inhibiting bone resorption, which is believed to help alleviate pain and improve function. It is classified as a bisphosphonate, a type of medication that affects bone metabolism.

Investigated diseases

Low Back Pain – Low back pain is a common condition characterized by discomfort or pain in the lower back area. It can be caused by various factors, including muscle strain, poor posture, or underlying conditions such as arthritis. The pain may be acute, lasting a few days to weeks, or chronic, persisting for more than three months. Individuals with low back pain may experience stiffness, limited range of motion, and difficulty performing daily activities. The condition can vary in intensity, from mild to severe, and may be accompanied by sensations such as tingling or numbness. Over time, low back pain can lead to changes in posture and movement patterns as individuals try to avoid discomfort.