Efficiency and Safety Study of Pamidronate in Inflammatory Back Pain Due to Degenerative Disk Disease

February 25, 2013 updated by: University Hospital, Clermont-Ferrand
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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

48

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont-Ferrand, France, 63003
        • Recruiting
        • CHU Clermont-Ferrand

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pamidronate
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
Drug: Pamidronate
Other: Placebo
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
Other: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
back pain assessed on a100mm VAS
Time Frame: at 3 months
at 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
- Functional status using EIFEL, Dallas, FABQ, MacTar, and MCII/PASS questionnaires
Time Frame: at 6 weeks, 3 months, and 6 months
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
at 6 weeks, 3 months, and 6 months
Inflammatory pain pattern
Time Frame: at 6 weeks, 3 months, and 6 months
Inflammatory pain pattern: number of nightly awakenings, as well as duration and intensity of morning stiffness on a 100mm VAS
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
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
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
at 6 weeks, 3 months, and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Collaborators

INSERM CIC 501

Investigators

  • Principal Investigator: Martin SOUBRIER, University Hospital, Clermont-Ferrand

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Anticipated)

January 1, 2015

Study Completion (Anticipated)

March 1, 2015

Study Registration Dates

First Submitted

February 21, 2013

First Submitted That Met QC Criteria

February 25, 2013

First Posted (Estimate)

February 27, 2013

Study Record Updates

Last Update Posted (Estimate)

February 27, 2013

Last Update Submitted That Met QC Criteria

February 25, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHU-0148
  • 2012-003569-16

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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