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.

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01803360

Enrollment

Registered

2013-03-04

Start date

2013-03-31

Completion date

2013-09-30

Last updated

2013-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis, Knee

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.

Interventions

DRUGNeridronate

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
knee pain reduction	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

Measure	Time frame
Bone marrow lesions reduction	60 days

Countries

Italy

Contacts

Primary ContactMassimo Varenna

varenna@gpini.it00390258296897

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026