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

• Status: Unknown status
• Trial end date: 2015-03-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Clermont-Ferrand
• Collaborator: INSERM CIC 501
• Treatments: Pamidronate

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