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

ASST Gaetano Pini-CTO60 enrolled

Overview

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Osteoarthritis, Knee

Interventions

NeridronateDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Istituto Ortopedico Gaetano Pini

Milan, MI, Italy

RECRUITING

Outcomes

Primary Outcomes

knee pain reduction

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)

Time frame: 60 days

Secondary Outcomes

Bone marrow lesions reduction

Time frame: 60 days

Central Contacts

Massimo Varenna

CONTACT

00390258296897 varenna@gpini.it

Data from ClinicalTrials.gov

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