Trial | NCT01803360  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    60
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 Started
Mar 31
2013
Primary Completion
Jul 31
2013
Anticipated
Study Completion
Sep 30
2013
Anticipated
Last Update
Mar 14
2013
Estimate

Drug Neridronate

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

Neridronate Experimental

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

Placebo Placebo Comparator

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

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
No Results Posted