Efficacy Study of Neridronate to Treat Painful Osteoarthritis of the Knee With Bone Marrow Lesions.

Brief Summary

Official Title: “A Randomized, Double-blind, Placebo Controlled Trial to Assess the Efficacy of Neridronate 100 mg -4 i.v. Infusions- in Patients With Painful Osteoarthritis of the Knee With Bone Marrow Lesions.”

The purpose of this study is to determine whether neridronate is effective in the treatment of pain related to bone marrow oedema in patients with osteoarthritis of the knee.

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
  • Study Primary Completion Date: July 2013

Interventions Used in this Clinical Trial

  • Drug: Neridronate
    • Neridronate 100 mg solution for infusion: 4 intravenous administrations in a course of 10 days treatment

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: Neridronate
    • Neridronate 100 mg solution for infusion: 4 intravenous administrations in a course of 10 days treatment
  • Placebo Comparator: Placebo
    • Saline solution for infusion: 4 intravenous administrations in a course of 10 days treatment

Outcome Measures for this Clinical Trial

Primary Measures

  • knee pain reduction
    • Time Frame: 60 days
      Safety Issue?: No

Secondary Measures

  • Bone marrow lesions reduction
    • Time Frame: 60 days
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion Criteria

  • Clinical diagnosis of knee Osteoarthritis (ACR criteria)
  • Radiographic diagnosis of knee Osteoarthritis (Kellgren/Lawrence scale >=2)
  • >4 weeks but <3 months pain, reported as >30 mm on a 100 mm VAS scale
  • bone marrow oedema of the affected knee on magnetic resonance

Exclusion Criteria

  • inflammatory arthritis
  • aseptic osteonecrosis of the knee
  • previous or current treatment with Bisphosphonates
  • serum calcium or creatinine abnormalities

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

  • Lead Sponsor
    • Istituto Ortopedico Gaetano Pini
  • Provider of Information About this Clinical Study
    • Principal Investigator: Massimo Varenna, MD PhD – Istituto Ortopedico Gaetano Pini
  • Overall Contact(s)
    • Massimo Varenna, 00390258296897, varenna@gpini.it

Source

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT01803360