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

This study is currently recruiting participants.
Verified February 2013 by University Hospital, Clermont-Ferrand
Sponsor:
Collaborator:
INSERM CIC 501
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT01799616
First received: February 21, 2013
Last updated: February 25, 2013
Last verified: February 2013
History of Changes
  Purpose

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


Condition Intervention Phase
Intervertebral Disc Degeneration
Modic I Discopathy
Back Pain
Low Back Pain
Magnetic Resonance Imaging (MRI)
 Drug: Pamidronate
Other: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Clermont-Ferrand:

Primary Outcome Measures:
  • back pain assessed on a100mm VAS [ Time Frame: at 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • - Functional status using EIFEL, Dallas, FABQ, MacTar, and MCII/PASS questionnaires [ Time Frame: at 6 weeks, 3 months, and 6 months ] [ Designated as safety issue: Yes ]
  • Back stiffness assessed by Schober's test and finger-to-floor distance [ Time Frame: at 6 weeks, 3 months, and 6 months ] [ Designated as safety issue: Yes ]
  • Inflammatory pain pattern [ Time Frame: at 6 weeks, 3 months, and 6 months ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 48
Study Start Date: January 2013
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01799616

Contacts
Contact: Patrick LACARIN 04 73 75 11 95 placarin@chu-clermontferrand.fr

Locations
France
CHU Clermont-Ferrand Recruiting
Clermont-Ferrand, France, 63003
Contact: Patrick LACARIN     04 73 75 11 95     placarin@chu-clermontferrand.fr    
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
INSERM CIC 501
Investigators
Principal Investigator: Martin SOUBRIER University Hospital, Clermont-Ferrand
  More Information

No publications provided

Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT01799616     History of Changes
Other Study ID Numbers: CHU-0148, 2012-003569-16
Study First Received: February 21, 2013
Last Updated: February 25, 2013
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Clermont-Ferrand:
MODIC changes
Chronic low back pain
Pamidronate
 Magnetic resonance imaging
Vertebrae
Intervertebral disc

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Intervertebral Disk Degeneration
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
 Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Pamidronate
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013