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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2013 by Massimo Varenna, Istituto Ortopedico Gaetano Pini.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01803360
First Posted: March 4, 2013
Last Update Posted: March 14, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Massimo Varenna, Istituto Ortopedico Gaetano Pini
  Purpose
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.

Condition Intervention Phase
Osteoarthritis, Knee Drug: Neridronate Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Massimo Varenna, Istituto Ortopedico Gaetano Pini:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • Bone marrow lesions reduction [ Time Frame: 60 days ]

Estimated Enrollment: 60
Study Start Date: March 2013
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01803360


Contacts
Contact: Massimo Varenna 00390258296897 varenna@gpini.it

Locations
Italy
Istituto Ortopedico Gaetano Pini Recruiting
Milano, MI, Italy, 20122
Contact: Massimo Varenna    00390258296897    varenna@gpini.it   
Principal Investigator: Massimo Varenna         
Sponsors and Collaborators
ASST Gaetano Pini-CTO
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Massimo Varenna, MD PhD, Istituto Ortopedico Gaetano Pini
ClinicalTrials.gov Identifier: NCT01803360     History of Changes
Other Study ID Numbers: NERI-OA-2013
First Submitted: March 1, 2013
First Posted: March 4, 2013
Last Update Posted: March 14, 2013
Last Verified: March 2013

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases