Efficacy Study of Neridronate to Treat Painful Osteoarthritis of the Knee With Bone Marrow Lesions.
NCT ID: NCT01803360
Last Updated: 2013-03-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
60 participants
INTERVENTIONAL
2013-03-31
2013-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Neridronate
Neridronate 100 mg solution for infusion: 4 intravenous administrations in a course of 10 days treatment
Neridronate
Neridronate 100 mg solution for infusion: 4 intravenous administrations in a course of 10 days treatment
Placebo
Saline solution for infusion: 4 intravenous administrations in a course of 10 days treatment
No interventions assigned to this group
Interventions
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Neridronate
Neridronate 100 mg solution for infusion: 4 intravenous administrations in a course of 10 days treatment
Eligibility Criteria
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Inclusion 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
* aseptic osteonecrosis of the knee
* previous or current treatment with Bisphosphonates
* serum calcium or creatinine abnormalities
18 Years
ALL
No
Sponsors
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ASST Gaetano Pini-CTO
OTHER
Responsible Party
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Massimo Varenna
MD PhD
Locations
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Istituto Ortopedico Gaetano Pini
Milan, MI, Italy
Countries
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Central Contacts
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Facility Contacts
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References
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Varenna M, Zucchi F, Failoni S, Becciolini A, Berruto M. Intravenous neridronate in the treatment of acute painful knee osteoarthritis: a randomized controlled study. Rheumatology (Oxford). 2015 Oct;54(10):1826-32. doi: 10.1093/rheumatology/kev123. Epub 2015 May 20.
Other Identifiers
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NERI-OA-2013
Identifier Type: -
Identifier Source: org_study_id
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