NCT01799616

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
48

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2013

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 21, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 27, 2013

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

February 27, 2013

Status Verified

February 1, 2013

Enrollment Period

2 years

First QC Date

February 21, 2013

Last Update Submit

February 25, 2013

Conditions

Intervertebral Disc DegenerationModic I DiscopathyBack PainLow Back PainMagnetic Resonance Imaging (MRI)

Keywords

MODIC changesChronic low back painPamidronateMagnetic resonance imagingVertebraeIntervertebral disc

Outcome Measures

Primary Outcomes (1)

  • back pain assessed on a100mm VAS

    at 3 months

Secondary Outcomes (5)

  • - Functional status using EIFEL, Dallas, FABQ, MacTar, and MCII/PASS questionnaires

    at 6 weeks, 3 months, and 6 months

  • Back stiffness assessed by Schober's test and finger-to-floor distance

    at 6 weeks, 3 months, and 6 months

  • Inflammatory pain pattern

    at 6 weeks, 3 months, and 6 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

    at 6 weeks, 3 months, and 6 months

Study Arms (2)

Pamidronate

EXPERIMENTAL

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

OTHER

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

Interventions

PamidronateDRUG
Pamidronate
PlaceboOTHER
Placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • \- 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

You may not qualify if:

  • \- 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

RECRUITING

Related Publications (1)

  • 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.

    PMID: 24716739DERIVED

MeSH Terms

Conditions

Intervertebral Disc DegenerationBack PainLow Back Pain

Interventions

Pamidronate

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic Chemicals

Study Officials

  • Martin SOUBRIER

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick LACARIN

CONTACT

04 73 75 11 95placarin@chu-clermontferrand.fr

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2013

First Posted

February 27, 2013

Study Start

January 1, 2013

Primary Completion

January 1, 2015

Study Completion

March 1, 2015

Last Updated

February 27, 2013

Record last verified: 2013-02

Locations

FR(1)