NCT01803360
Unknown
Phase 2
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.
ASST Gaetano Pini-CTO1 site in 1 country60 target enrollmentMarch 2013
Overview
- Phase
- Phase 2
- Intervention
- Neridronate
- Conditions
- Osteoarthritis, Knee
- Sponsor
- ASST Gaetano Pini-CTO
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- knee pain reduction
- Last Updated
- 13 years ago
Overview
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.
Investigators
Massimo Varenna
MD PhD
ASST Gaetano Pini-CTO
Eligibility 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
Arms & Interventions
Neridronate
Neridronate 100 mg solution for infusion: 4 intravenous administrations in a course of 10 days treatment
Intervention: Neridronate
Outcomes
Primary Outcomes
knee pain reduction
Time Frame: 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 Outcomes
- Bone marrow lesions reduction(60 days)
Study Sites (1)
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