Efficiency and Safety Study of Pamidronate in Inflammatory Back Pain Due to Degenerative Disk Dis… (NCT01799616) | Clinical Trial Compass
UnknownPhase 2
Efficiency and Safety Study of Pamidronate in Inflammatory Back Pain Due to Degenerative Disk Disease
France48 participantsStarted 2013-01
Plain-language 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
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* \- 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
* Modic 1 discopathy (diagnosed on MRI and confirmed by trained radiologist)
* Dental check-up within the last 6 months
* Signed informed consent
Exclusion Criteria:
* \- 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
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.