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.
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Mar 2013
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 1, 2013
CompletedStudy Start
First participant enrolled
March 1, 2013
CompletedFirst Posted
Study publicly available on registry
March 4, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2013
CompletedMarch 14, 2013
March 1, 2013
4 months
March 1, 2013
March 13, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
knee pain reduction
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)
60 days
Secondary Outcomes (1)
Bone marrow lesions reduction
60 days
Study Arms (2)
Neridronate
EXPERIMENTALNeridronate 100 mg solution for infusion: 4 intravenous administrations in a course of 10 days treatment
Placebo
PLACEBO COMPARATORSaline solution for infusion: 4 intravenous administrations in a course of 10 days treatment
Interventions
Neridronate 100 mg solution for infusion: 4 intravenous administrations in a course of 10 days treatment
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- inflammatory arthritis
- aseptic osteonecrosis of the knee
- previous or current treatment with Bisphosphonates
- serum calcium or creatinine abnormalities
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Istituto Ortopedico Gaetano Pini
Milan, MI, 20122, Italy
Related Publications (1)
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.
PMID: 25998450DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD PhD
Study Record Dates
First Submitted
March 1, 2013
First Posted
March 4, 2013
Study Start
March 1, 2013
Primary Completion
July 1, 2013
Study Completion
September 1, 2013
Last Updated
March 14, 2013
Record last verified: 2013-03