Back to resultsEfficacy Study of Neridronate to Treat Painful Osteoarthritis of the Knee With Bone Marrow Lesions.
Primary Purpose
Osteoarthritis, Knee
Status
Unknown status
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Neridronate
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis, Knee
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
Sites / Locations
- Istituto Ortopedico Gaetano PiniRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Neridronate
Placebo
Arm Description
Neridronate 100 mg solution for infusion: 4 intravenous administrations in a course of 10 days treatment
Saline solution for infusion: 4 intravenous administrations in a course of 10 days treatment
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Bone marrow lesions reduction
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01803360
Brief Title
Efficacy Study of Neridronate to Treat Painful Osteoarthritis of the Knee With Bone Marrow Lesions.
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Unknown status
Study Start Date
March 2013 (undefined)
Primary Completion Date
July 2013 (Anticipated)
Study Completion Date
September 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
ASST Gaetano Pini-CTO
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Neridronate
Arm Type
Experimental
Arm Description
Neridronate 100 mg solution for infusion: 4 intravenous administrations in a course of 10 days treatment
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Saline solution for infusion: 4 intravenous administrations in a course of 10 days treatment
Intervention Type
Drug
Intervention Name(s)
Neridronate
Intervention Description
Neridronate 100 mg solution for infusion: 4 intravenous administrations in a course of 10 days treatment
Primary Outcome Measure Information:
Title
knee pain reduction
Description
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)
Time Frame
60 days
Secondary Outcome Measure Information:
Title
Bone marrow lesions reduction
Time Frame
60 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Massimo Varenna
Phone
00390258296897
Email
varenna@gpini.it
Facility Information:
Facility Name
Istituto Ortopedico Gaetano Pini
City
Milano
State/Province
MI
ZIP/Postal Code
20122
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Massimo Varenna
Phone
00390258296897
Email
varenna@gpini.it
First Name & Middle Initial & Last Name & Degree
Massimo Varenna
12. IPD Sharing Statement
Citations:
PubMed Identifier
25998450
Citation
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.
Results Reference
derived
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Efficacy Study of Neridronate to Treat Painful Osteoarthritis of the Knee With Bone Marrow Lesions.
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