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

Low Back Pain Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01799616
• Other study ID #: CHU-0148
• Secondary ID: 2012-003569-16
• Status: Recruiting
• Phase: Phase 2
• First received: February 21, 2013
• Last updated: February 25, 2013
• Start date: January 2013
• Est. completion date: March 2015

Study information

• Verified date: February 2013
• Source: University Hospital, Clermont-Ferrand
• Contact: Patrick LACARIN
• Phone: 04 73 75 11 95
• Email: placarin[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: March 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Back Pain
• Intervertebral Disc Degeneration
• Low Back Pain
• Magnetic Resonance Imaging (MRI)
• Modic I Discopathy

Intervention

Drug:
• Pamidronate

Other:
• Placebo

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand	INSERM CIC 501

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	back pain assessed on a100mm VAS		at 3 months	No
Secondary	- Functional status using EIFEL, Dallas, FABQ, MacTar, and MCII/PASS questionnaires		at 6 weeks, 3 months, and 6 months	Yes
Secondary	Back stiffness assessed by Schober's test and finger-to-floor distance		at 6 weeks, 3 months, and 6 months	Yes
Secondary	Inflammatory pain pattern	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	Yes
Secondary	assess the efficacy of a rigid back brace in treating back pain	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	Yes
Secondary	Tolerance based on the number and types of side-effects		at 6 weeks, 3 months, and 6 months	Yes