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

ASST Gaetano Pini-CTO

Status and phase: Unknown; Phase 2

Conditions: Osteoarthritis, Knee

Treatments: Drug: Neridronate

Study type: Interventional

Funder types: Other

Identifiers

NCT01803360

NERI-OA-2013

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

Neridronate

Experimental group

Description:

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

Treatment:

Drug: Neridronate

Placebo

Placebo Comparator group

Description:

Saline solution for infusion: 4 intravenous administrations in a course of 10 days treatment