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

March 13, 2013 updated by: Massimo Varenna, ASST Gaetano Pini-CTO

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
    • MI
      • Milano, MI, Italy, 20122
        • Recruiting
        • Istituto Ortopedico Gaetano Pini
        • Contact:
        • Principal Investigator:
          • Massimo Varenna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Neridronate
Neridronate 100 mg solution for infusion: 4 intravenous administrations in a course of 10 days treatment
Drug: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
knee pain reduction
Time Frame: 60 days
to assess the efficacy in terms of proportion of patients with a 50% reduction in pain intensity compared to baseline measured by VAS 100 mm scale recorded at the last visit (day 60)
60 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Bone marrow lesions reduction
Time Frame: 60 days
60 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ASST Gaetano Pini-CTO

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Anticipated)

July 1, 2013

Study Completion (Anticipated)

September 1, 2013

Study Registration Dates

First Submitted

March 1, 2013

First Submitted That Met QC Criteria

March 1, 2013

First Posted (Estimate)

March 4, 2013

Study Record Updates

Last Update Posted (Estimate)

March 14, 2013

Last Update Submitted That Met QC Criteria

March 13, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NERI-OA-2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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