Efficacy Study of Neridronate to Treat Painful Osteoarthritis of the Knee With Bone Marrow Lesions.
- Registration Number
- NCT01803360
- Lead Sponsor
- ASST Gaetano Pini-CTO
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Neridronate Neridronate Neridronate 100 mg solution for infusion: 4 intravenous administrations in a course of 10 days treatment
- Primary Outcome Measures
Name Time Method knee pain reduction 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
Name Time Method Bone marrow lesions reduction 60 days
Trial Locations
- Locations (1)
Istituto Ortopedico Gaetano Pini
🇮🇹Milano, MI, Italy