Efficacy Study of Neridronate to Treat Painful Osteoarthritis of the Knee With Bone Marrow Lesions.

Osteoarthritis, Knee Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01803360
• Other study ID #: NERI-OA-2013
• Status: Recruiting
• Phase: Phase 2
• First received: March 1, 2013
• Last updated: March 13, 2013
• Start date: March 2013
• Est. completion date: September 2013

Study information

• Verified date: March 2013
• Source: ASST Gaetano Pini-CTO
• Contact: Massimo Varenna
• Phone: 00390258296897
• Email: varenna[@]gpini.it
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• Neridronate
Neridronate 100 mg solution for infusion: 4 intravenous administrations in a course of 10 days treatment

Locations

Country	Name	City	State
Italy	Istituto Ortopedico Gaetano Pini	Milano	MI

Sponsors (1)

Lead Sponsor	Collaborator
ASST Gaetano Pini-CTO

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Bone marrow lesions reduction		60 days	No