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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Istituto Ortopedico Gaetano Pini
Sponsor:
Information provided by (Responsible Party):
Massimo Varenna, Istituto Ortopedico Gaetano Pini
ClinicalTrials.gov Identifier:
NCT01803360
First received: March 1, 2013
Last updated: March 13, 2013
Last verified: March 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 Istituto Ortopedico Gaetano Pini:

Primary Outcome Measures:
  • knee pain reduction [ Time Frame: 60 days ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Istituto Ortopedico Gaetano Pini
  More Information

No publications provided

Responsible Party: Massimo Varenna, MD PhD, Istituto Ortopedico Gaetano Pini
ClinicalTrials.gov Identifier: NCT01803360     History of Changes
Other Study ID Numbers: NERI-OA-2013
Study First Received: March 1, 2013
Last Updated: March 13, 2013
Health Authority: Italy: Ethics Committee

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

ClinicalTrials.gov processed this record on August 01, 2014