NCT01803360

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 Phase 2 Last updated 13 March 2013

What this trial tests

Phase 2 trial testing Neridronate in Osteoarthritis, Knee in 60 participants. Status unknown.

Timeline

1 March 2013

Primary endpoint
1 July 2013

1 September 2013

Quick facts

Lead sponsor	ASST Gaetano Pini-CTO
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	60
Start date	1 March 2013
Primary completion	1 July 2013
Estimated completion	1 September 2013
Sites	1 location across Italy

Drugs / interventions tested

• Neridronate (NERIDRONIC ACID) — full drug profile →

Conditions studied

• Osteoarthritis, Knee — all drugs for Osteoarthritis, Knee →

Sponsor

ASST Gaetano Pini-CTO — full company profile →

Who can join

18 and older, any sex, with Osteoarthritis, Knee. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• knee pain reduction
  Time frame: 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)

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Intravenous neridronate in the treatment of acute painful knee osteoarthritis: a randomized controlled study.
   Varenna M, Zucchi F, Failoni S, Becciolini A, et al · · 2015 · cited 39× · PMID 25998450 · DOI 10.1093/rheumatology/kev123
2. Pharmaceutical therapeutics for articular regeneration and restoration: state-of-the-art technology for screening small molecular drugs.
   Chen Y, Sun H, Yao X, Yu Y, et al · · 2021 · cited 9× · PMID 34783870 · DOI 10.1007/s00018-021-03983-8