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

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ClinicalTrials.gov Identifier: NCT01799616
Recruitment Status : Unknown
Verified February 2013 by University Hospital, Clermont-Ferrand.
Recruitment status was:  Recruiting
First Posted : February 27, 2013
Last Update Posted : February 27, 2013
Sponsor:
Collaborator:
INSERM CIC 501
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

Tracking Information
First Submitted Date  ICMJE February 21, 2013
First Posted Date  ICMJE February 27, 2013
Last Update Posted Date February 27, 2013
Study Start Date  ICMJE January 2013
Estimated Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 25, 2013)
back pain assessed on a100mm VAS [ Time Frame: at 3 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 25, 2013)
  • - 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 ]
    Inflammatory pain pattern: number of nightly awakenings, as well as duration and intensity of morning stiffness on a 100mm VAS
  • 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
  • Tolerance based on the number and types of side-effects [ Time Frame: at 6 weeks, 3 months, and 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficiency and Safety Study of Pamidronate in Inflammatory Back Pain Due to Degenerative Disk Disease
Official Title  ICMJE Not Provided
Brief 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
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Intervertebral Disc Degeneration
  • Modic I Discopathy
  • Back Pain
  • Low Back Pain
  • Magnetic Resonance Imaging (MRI)
Intervention  ICMJE
  • Drug: Pamidronate
  • Other: Placebo
Study Arms  ICMJE
  • 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
    Intervention: Drug: Pamidronate
  • 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
    Intervention: Other: Placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 25, 2013)
48
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2015
Estimated Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01799616
Other Study ID Numbers  ICMJE CHU-0148
2012-003569-16
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Clermont-Ferrand
Study Sponsor  ICMJE University Hospital, Clermont-Ferrand
Collaborators  ICMJE INSERM CIC 501
Investigators  ICMJE
Principal Investigator: Martin SOUBRIER University Hospital, Clermont-Ferrand
PRS Account University Hospital, Clermont-Ferrand
Verification Date February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP